EMA IRIS Inspections Industry training on GMP & GCP (youtube.com)
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so the agenda that we have for today is
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is as i said it's quite heavy um
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so we will start with a bit of
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introduction of the team then we will
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move on to do a bit of recap on what
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iris is because i'm not sure if you're
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all familiar with it
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then we will have a session on
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registration and access management to
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the system
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we will move on to the planned go lives
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for the various inspection types that we
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are on boarding in iris
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we will talk a bit about the gmp
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business process
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then we will do the same but focusing on
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the gcp business process you will see
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that there aren't many differences but
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there are some specificities that we
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want to highlight to you then we will uh
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present to you the notifications and i
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think this point would be very important
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because it's about how ema will
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communicate with all of you with your
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companies which are applicants or mahs
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for centrally authorized products
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so
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keep an eye on this one because i think
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you will all find it important
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then we will talk a bit about the next
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steps so that you know what's coming
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after this training session
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and then we will show you a video and
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that displays how the industry portal
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works in practice because the industry
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portal is the actual interface that you
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will use to communicate with ema
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and we will of course
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tell you how you can use it and and this
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includes um both gmp and gcp inspections
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and then as i said we will have a bit of
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time to to cover questions and answers
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so please feel free to
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write your questions in the chat
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as they come up and we will collect them
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and as i said answer at the end of the
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presentation
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so i already introduced myself but as
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you can imagine i'm not alone
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this is a project that really
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characterizes for like any other project
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like
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by um strong team work
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and this wouldn't be possible if it
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wasn't for the people that you have on
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the screen right now so you can see at
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the top
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my colleague dunya she's with me in the
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room today and she's our subject matter
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expert for pharmacovigilance inspections
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we also have miguel who is our expert on
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gcp inspections and you will have the
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chance to to hear his voice because he
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will touch on the points related to gcp
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we also have another colleague baptist
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who is focused on gmp inspections
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and last but not least we have carlo de
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vitoria who will explain more about the
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access management he's an information
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security officer at ema and also our
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business analyst delia who has kindly
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put together the videos that we will be
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showing you and who has been uh
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supporting us um
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in in in an amazing way so
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this is the team today
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and what i'm gonna do now is i'm gonna
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tell you a bit of what it is about
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so first of all maybe a bit of
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background as to why we're doing this
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and i'm sure this is not something that
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is new to you i'm sure in your
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organizations you've been experiencing
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this digital business transformation and
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i guess the drivers for such
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transformation are not so different
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in our case as you know ema supports
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coordinates and operates a significant
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number of regulatory procedures and this
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goes across the life cycle of the
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medicinal product from pre-submission to
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post-authorization through evaluation
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for both human and veterinary medicines
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and the procedure management systems
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that support these activities actually
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have grown
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tremendously over a number of decades
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in part b
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because of the pieces of legislation
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that have come
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into application over the past 25 years
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so there is a need for ema to invest in
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its core processes upgrade because some
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of the systems and technology that are
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supporting these regulatory procedures
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are now over a decade old and as you can
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imagine they result in very high
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maintenance costs
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so
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the aim is that by improving our
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internal corporate id tools we will be
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able to continue to support the eu
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medicine regulatory network and its
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stakeholders and in this case we have
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you as key stakeholders
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industry
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in an efficient and sustainable manner
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so in summary we need to evolve
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digitally to be able to respond to all
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the environmental influences brought by
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not only legislative initiatives but
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also technology innovation
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global trends and increasing
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stakeholders needs and
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expectations so what is id so iris is
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essentially an information management
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platform and
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some of you or perhaps some of your
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colleagues in your companies are already
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familiar with it because iris is up and
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running for a number of procedures
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that we manage at ema for example
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parallel distribution or
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orphan designation
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scientific advice innovation task force
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and more recently marketing status
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so it's a secure online platform for the
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handling of product related scientific
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and regulatory procedures within ema
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what you have at the bottom of the
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screen
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is the
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the link to the iris portal which of
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course this is the public home page
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so once you have the relevant uh
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credentials once you are idis users you
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will be able to access through this link
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so what are the objectives of of this
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new platform well on the one hand um
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it's
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one objective is to offer a more secure
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and digital
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way of sharing information
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and on the other hand is to be more
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efficient and and offer a collaborative
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way of working
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so
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we are trying to move away from utrelink
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as you know at the moment we are using
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neutralink
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to communicate with companies quite
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heavily
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so we are trying to move away from this
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we are trying to automate our processes
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um
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avoid having to re-key information
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offer
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a platform where inspectors can
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collaborate together
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and also
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connect with the
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master data management system at the anc
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you might have heard of spore which
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stands for substances products
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organizations and referentials
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so let's talk maybe a bit more about the
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technology and the components of iris so
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we can summarize iris into let's say
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three sides
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plus a document repository so i'm going
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to start with the last one the document
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repository
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the one that we are using is actually
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sharepoint and as you know sharepoint is
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a cloud-based file storage
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and this is accessed by the eu
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regulatory network of course and by ema
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staff
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and you as company users you will also
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be able to access
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certain areas of sharepoint the idea is
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that this will offer execute platform
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for document sharing and viewing in
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addition to the repository we have what
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we call crm which is the customer
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relationship management system which is
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the interface that ema staff uses so
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when we receive an application and we
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need to validate process that
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application we will do so
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through crm in addition we have two
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portals we have on the one hand the
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network portal which is the interface
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that is used by eu regulatory network so
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meaning the ncas and we have the
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industry portal which is the interface
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that you will be using as industry
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stakeholders and this is
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the interface that you use to provide
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data and documents and this will replace
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um the use of user link at the moment
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that we have for the provisional of such
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information and going a bit deeper into
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the actual technicalities of the
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technology as i said iris is cloud-based
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and you can see that we are using
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microsoft azure for the
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managing the
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um
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the access so we have a platform that is
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the ema identity and access management
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platform that is based on this
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technology then we use microsoft
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dynamics and this is the technology
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supporting the industry portal the
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network portal
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the crm portal and also the public
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registers you can see that some of the
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pillars under these portals are actually
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related to when i mentioned earlier to
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spore so the master data management
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system of the agency which is split into
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four pillars
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oms that looks after organizations
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rms that looks after referentials sms
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that looks after substances and pms that
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looks after product management and we
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also have a connection with sap finance
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of course and with other ema systems and
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database and the third component is
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office 365 and this is supporting
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sharepoint so the document repository as
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well as microsoft teams so a bit of
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recap and even though
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here at the top it says key benefits for
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network users actually we could say that
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these are the key benefits for
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stakeholder users in general
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we believe that this provides
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efficiency because we will have in a
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single portal
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all inspection procedures and documents
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related and it's a user-friendly
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interface we think that it will save
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time for you for the inspectors and for
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ourselves because you will have
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immediate access to the information
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and you don't need to download or to
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send anything by utralink there is also
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better visibility
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you can check the status online and you
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have 24 7 real-time access
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but their usability because you will be
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able to log in not only using your pc
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but also using your tablet or your phone
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and as i mentioned earlier it's a more
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secured platform because the documents
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are uploaded in sharepoint and they are
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not circulated by email or utah link
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there is one more aspect we want to
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highlight and this is a an additional as
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a channel of communication that we have
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within this platform
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which is called id stakeholder forums
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so we use these for news
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from ema
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and
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the
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the beauty of of this forum is that
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you can access it publicly you don't
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need to have a username or a password to
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read the threads you only need um
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credentials to
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to write and reply so to login it's
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already up and running and this is an
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00:11:59,920 --> 00:12:05,600
additional channel on top of the ema
287
00:12:03,040 --> 00:12:08,639
service desk and ask ema
288
00:12:05,600 --> 00:12:10,720
so i would encourage all of you to go to
289
00:12:08,639 --> 00:12:12,800
the link that i showed earlier and have
290
00:12:10,720 --> 00:12:14,480
a look at the forums because you might
291
00:12:12,800 --> 00:12:16,399
already find
292
00:12:14,480 --> 00:12:18,560
news or
293
00:12:16,399 --> 00:12:20,959
instructions that might be helpful i'm
294
00:12:18,560 --> 00:12:23,120
gonna go now a bit into the high level
295
00:12:20,959 --> 00:12:25,200
business process it is really high level
296
00:12:23,120 --> 00:12:27,839
but i thought it was important to
297
00:12:25,200 --> 00:12:29,120
show to you how the information flows in
298
00:12:27,839 --> 00:12:31,360
iris
299
00:12:29,120 --> 00:12:33,760
in in most of the procedures that we
300
00:12:31,360 --> 00:12:35,440
have already onboarded
301
00:12:33,760 --> 00:12:36,639
i mentioned for example scientific
302
00:12:35,440 --> 00:12:39,839
advice
303
00:12:36,639 --> 00:12:43,279
the flow starts normally with
304
00:12:39,839 --> 00:12:46,399
industry so with yourselves creating an
305
00:12:43,279 --> 00:12:49,519
online application and you do so via the
306
00:12:46,399 --> 00:12:52,480
industry portal once the submission is
307
00:12:49,519 --> 00:12:55,040
in the system a case is created
308
00:12:52,480 --> 00:12:56,240
and that case is managed through the crm
309
00:12:55,040 --> 00:12:59,120
interface
310
00:12:56,240 --> 00:13:02,720
so that ema can look at the application
311
00:12:59,120 --> 00:13:05,279
validate it if necessary and process it
312
00:13:02,720 --> 00:13:08,160
and then what we do is we expose the
313
00:13:05,279 --> 00:13:09,680
necessary information to the network so
314
00:13:08,160 --> 00:13:11,200
to nca's
315
00:13:09,680 --> 00:13:13,360
who might need to
316
00:13:11,200 --> 00:13:14,959
put together an assessment report or in
317
00:13:13,360 --> 00:13:17,440
the case of inspections and inspection
318
00:13:14,959 --> 00:13:19,200
report and we do this via the network
319
00:13:17,440 --> 00:13:21,680
portal the difference between the
320
00:13:19,200 --> 00:13:24,720
standard flow of information and the
321
00:13:21,680 --> 00:13:27,440
inspections flow is that as you know
322
00:13:24,720 --> 00:13:29,760
um inspections are not not triggered by
323
00:13:27,440 --> 00:13:31,120
industry inspections are triggered by
324
00:13:29,760 --> 00:13:33,040
regulators
325
00:13:31,120 --> 00:13:35,760
so you can see that here we have
326
00:13:33,040 --> 00:13:39,120
inverted the order of the first two
327
00:13:35,760 --> 00:13:42,399
boxes and the flow starts with ema
328
00:13:39,120 --> 00:13:43,760
creating an inspection case
329
00:13:42,399 --> 00:13:46,000
in crm
330
00:13:43,760 --> 00:13:47,120
and then pushing it to process the
331
00:13:46,000 --> 00:13:48,959
inspection
332
00:13:47,120 --> 00:13:51,040
so what happens is that once we have
333
00:13:48,959 --> 00:13:52,639
created the case and the relevant
334
00:13:51,040 --> 00:13:56,800
committee
335
00:13:52,639 --> 00:13:57,760
chmp or cvmp has adopted the inspection
336
00:13:56,800 --> 00:14:00,560
then
337
00:13:57,760 --> 00:14:03,120
submissions are automatically created
338
00:14:00,560 --> 00:14:04,560
for each of the mah
339
00:14:03,120 --> 00:14:06,320
for which there is a product in the
340
00:14:04,560 --> 00:14:08,800
scope of the inspection
341
00:14:06,320 --> 00:14:11,680
so you don't need to submit or to create
342
00:14:08,800 --> 00:14:14,560
a submission you will be notified that a
343
00:14:11,680 --> 00:14:16,720
submission has been created for you and
344
00:14:14,560 --> 00:14:19,600
you will be able to access the details
345
00:14:16,720 --> 00:14:22,320
of of such submission via the industry
346
00:14:19,600 --> 00:14:24,639
portal this will also allow you to enter
347
00:14:22,320 --> 00:14:26,639
data and submit documents and the last
348
00:14:24,639 --> 00:14:28,839
part is is the same as before so we
349
00:14:26,639 --> 00:14:31,279
expose the necessary information to the
350
00:14:28,839 --> 00:14:33,920
network and we do it via the network
351
00:14:31,279 --> 00:14:35,600
portal in the case of inspections the
352
00:14:33,920 --> 00:14:39,120
inspectors will be uploading the
353
00:14:35,600 --> 00:14:40,959
inspection reports through sharepoint so
354
00:14:39,120 --> 00:14:43,519
when we talk about the inspections in
355
00:14:40,959 --> 00:14:44,959
iris and the onboarding of inspections
356
00:14:43,519 --> 00:14:47,040
in iris
357
00:14:44,959 --> 00:14:49,199
which kinds of inspections are we really
358
00:14:47,040 --> 00:14:51,279
talking about and i think it's important
359
00:14:49,199 --> 00:14:54,079
that we repeat
360
00:14:51,279 --> 00:14:55,839
what is really the scope of this project
361
00:14:54,079 --> 00:14:58,480
we are talking about three types of
362
00:14:55,839 --> 00:15:01,120
inspections and these are gmp
363
00:14:58,480 --> 00:15:02,720
gcp and pharmacovigilance inspections
364
00:15:01,120 --> 00:15:04,240
you may know that
365
00:15:02,720 --> 00:15:06,959
at ema we
366
00:15:04,240 --> 00:15:09,199
manage also other types of inspections
367
00:15:06,959 --> 00:15:11,040
and these are for example pmf plasma
368
00:15:09,199 --> 00:15:13,199
master file and
369
00:15:11,040 --> 00:15:14,240
glp inspection so good laboratory
370
00:15:13,199 --> 00:15:16,720
practice
371
00:15:14,240 --> 00:15:19,839
but they are outside of this project and
372
00:15:16,720 --> 00:15:20,880
therefore they are not onboarded in iris
373
00:15:19,839 --> 00:15:23,760
so
374
00:15:20,880 --> 00:15:25,279
if any of your companies is involved in
375
00:15:23,760 --> 00:15:27,680
any of these
376
00:15:25,279 --> 00:15:29,600
inspections just bear in mind that we
377
00:15:27,680 --> 00:15:31,199
will continue with the current practice
378
00:15:29,600 --> 00:15:33,360
outside iris
379
00:15:31,199 --> 00:15:35,680
they may be considered later in the iris
380
00:15:33,360 --> 00:15:39,600
road map but for the time being they are
381
00:15:35,680 --> 00:15:42,240
excluded and with this i'm going to hand
382
00:15:39,600 --> 00:15:44,639
over to my colleague carlo de vittoria
383
00:15:42,240 --> 00:15:46,880
who's gonna explain a bit more about the
384
00:15:44,639 --> 00:15:48,320
registration in iris and the access
385
00:15:46,880 --> 00:15:51,680
management
386
00:15:48,320 --> 00:15:54,880
uh carlo i hope you can hear me we
387
00:15:51,680 --> 00:15:56,880
we need to unmute you so
388
00:15:54,880 --> 00:15:59,279
give us a second
389
00:15:56,880 --> 00:16:02,480
and i think you will be able to speak so
390
00:15:59,279 --> 00:16:03,279
carlo over to you thank you
391
00:16:02,480 --> 00:16:05,440
so
392
00:16:03,279 --> 00:16:07,759
as esther said my name is
393
00:16:05,440 --> 00:16:09,519
carlo de vittoria i work in the
394
00:16:07,759 --> 00:16:11,759
information security
395
00:16:09,519 --> 00:16:14,079
office
396
00:16:11,759 --> 00:16:17,360
my role is mainly to look after the
397
00:16:14,079 --> 00:16:18,160
identity and access management part
398
00:16:17,360 --> 00:16:19,360
so
399
00:16:18,160 --> 00:16:20,959
this is
400
00:16:19,360 --> 00:16:24,560
the high level flow
401
00:16:20,959 --> 00:16:27,759
that you will need to follow in iris
402
00:16:24,560 --> 00:16:30,720
in the ema account management platform
403
00:16:27,759 --> 00:16:31,519
the first time you register
404
00:16:30,720 --> 00:16:33,120
so
405
00:16:31,519 --> 00:16:35,600
if
406
00:16:33,120 --> 00:16:38,720
you never access artists before you need
407
00:16:35,600 --> 00:16:41,440
to go through the whole process instead
408
00:16:38,720 --> 00:16:44,160
if you already had access
409
00:16:41,440 --> 00:16:46,800
wires for other procedures or if other
410
00:16:44,160 --> 00:16:49,040
colleagues that had access
411
00:16:46,800 --> 00:16:51,120
to others for other procedures
412
00:16:49,040 --> 00:16:52,399
some of the steps that we are describing
413
00:16:51,120 --> 00:16:53,759
here can be
414
00:16:52,399 --> 00:16:55,920
can be skipped
415
00:16:53,759 --> 00:16:58,639
one super important prerequisite of
416
00:16:55,920 --> 00:17:01,279
course is that your organization exists
417
00:16:58,639 --> 00:17:05,120
in our master data management system for
418
00:17:01,279 --> 00:17:06,959
organization that is oms oms stands for
419
00:17:05,120 --> 00:17:09,919
organizational management system and
420
00:17:06,959 --> 00:17:13,039
this part of the sport system
421
00:17:09,919 --> 00:17:14,880
you can check if an organization
422
00:17:13,039 --> 00:17:17,039
is a registered
423
00:17:14,880 --> 00:17:18,600
director in the sport portal is
424
00:17:17,039 --> 00:17:20,160
available at
425
00:17:18,600 --> 00:17:22,480
sport.xml.tropo.u
426
00:17:20,160 --> 00:17:26,000
but you can look for an organization in
427
00:17:22,480 --> 00:17:29,280
other places like iris itself and also
428
00:17:26,000 --> 00:17:30,480
in the account management platform
429
00:17:29,280 --> 00:17:33,039
so
430
00:17:30,480 --> 00:17:35,039
when you need to request access as a
431
00:17:33,039 --> 00:17:37,280
first user of paris
432
00:17:35,039 --> 00:17:41,039
uh what you will need to do is to look
433
00:17:37,280 --> 00:17:43,520
for the iris user admin role
434
00:17:41,039 --> 00:17:47,039
for the industry and then you will need
435
00:17:43,520 --> 00:17:49,440
to attach an affiliation template
436
00:17:47,039 --> 00:17:53,120
that is signed by the company
437
00:17:49,440 --> 00:17:56,720
on which you access the data in br2
438
00:17:53,120 --> 00:17:59,760
we will see later so if a four party
439
00:17:56,720 --> 00:18:02,000
need to access nvr for the company the
440
00:17:59,760 --> 00:18:04,880
company need to drink it access to this
441
00:18:02,000 --> 00:18:07,039
four party via this affiliation letter
442
00:18:04,880 --> 00:18:08,880
and after you submit the request there
443
00:18:07,039 --> 00:18:11,760
is a further screen
444
00:18:08,880 --> 00:18:14,960
where you can select the organization
445
00:18:11,760 --> 00:18:17,360
and then this request as a first user
446
00:18:14,960 --> 00:18:20,160
administrator is always approved by the
447
00:18:17,360 --> 00:18:22,640
ema so we will verify the affiliation
448
00:18:20,160 --> 00:18:25,440
template later we will verify other
449
00:18:22,640 --> 00:18:27,840
information about the user requesting
450
00:18:25,440 --> 00:18:28,960
the user that is signing the form and
451
00:18:27,840 --> 00:18:31,600
then
452
00:18:28,960 --> 00:18:34,799
we will eventually approve or
453
00:18:31,600 --> 00:18:37,600
deny the request so this is only for the
454
00:18:34,799 --> 00:18:39,919
first user administrator all the other
455
00:18:37,600 --> 00:18:42,720
user administrators
456
00:18:39,919 --> 00:18:45,440
will be approved by the appointed user
457
00:18:42,720 --> 00:18:47,280
administrators so we always advise to
458
00:18:45,440 --> 00:18:49,679
have more than one
459
00:18:47,280 --> 00:18:51,919
so that the
460
00:18:49,679 --> 00:18:54,720
process will be resilient and we don't
461
00:18:51,919 --> 00:18:56,480
need to be involved
462
00:18:54,720 --> 00:18:59,440
when the user administrator
463
00:18:56,480 --> 00:19:00,960
is appointed then all other roles in rs
464
00:18:59,440 --> 00:19:02,640
can be requested
465
00:19:00,960 --> 00:19:05,360
if a
466
00:19:02,640 --> 00:19:07,600
user is trying to request a manager or a
467
00:19:05,360 --> 00:19:10,160
contribute winaris without a user
468
00:19:07,600 --> 00:19:12,400
administrator appointed the system will
469
00:19:10,160 --> 00:19:15,280
automatically reject the request so the
470
00:19:12,400 --> 00:19:17,919
first important thing is always to check
471
00:19:15,280 --> 00:19:20,000
that the user administrator is appointed
472
00:19:17,919 --> 00:19:22,480
for the organization
473
00:19:20,000 --> 00:19:25,520
when the user administrator is appointed
474
00:19:22,480 --> 00:19:27,200
then all other users can request access
475
00:19:25,520 --> 00:19:29,360
and this access
476
00:19:27,200 --> 00:19:31,440
is approved by the pool of user
477
00:19:29,360 --> 00:19:33,679
administrators that are appointed for
478
00:19:31,440 --> 00:19:34,640
that specific organization
479
00:19:33,679 --> 00:19:36,960
so
480
00:19:34,640 --> 00:19:41,120
in with this model we completely
481
00:19:36,960 --> 00:19:43,039
delegate to the organization to define
482
00:19:41,120 --> 00:19:45,679
the governance model that they want to
483
00:19:43,039 --> 00:19:48,480
have so who can access the system when
484
00:19:45,679 --> 00:19:50,480
they want to revoke access and the user
485
00:19:48,480 --> 00:19:52,320
administrator has the possibility of
486
00:19:50,480 --> 00:19:54,240
doing all this
487
00:19:52,320 --> 00:19:55,840
function in the account management
488
00:19:54,240 --> 00:19:57,280
system so
489
00:19:55,840 --> 00:19:59,039
some
490
00:19:57,280 --> 00:20:01,440
tips
491
00:19:59,039 --> 00:20:04,559
for the first user administrator as i
492
00:20:01,440 --> 00:20:08,400
said this is something that we as ama
493
00:20:04,559 --> 00:20:11,280
verify so it's really important that is
494
00:20:08,400 --> 00:20:12,720
coming with a work email a business
495
00:20:11,280 --> 00:20:14,799
email
496
00:20:12,720 --> 00:20:17,039
and it will really facilitate the
497
00:20:14,799 --> 00:20:19,760
approval if the email is coming from the
498
00:20:17,039 --> 00:20:22,159
same organization for which the user is
499
00:20:19,760 --> 00:20:24,559
requesting access in vr
500
00:20:22,159 --> 00:20:26,480
for the first user administrator
501
00:20:24,559 --> 00:20:28,159
we will tend to refuse all requests
502
00:20:26,480 --> 00:20:30,799
coming for
503
00:20:28,159 --> 00:20:33,039
private addresses like gmail yahoo and
504
00:20:30,799 --> 00:20:36,000
similars
505
00:20:33,039 --> 00:20:38,559
as i said we recommend to have more than
506
00:20:36,000 --> 00:20:42,320
one user administrator because this will
507
00:20:38,559 --> 00:20:45,120
allow you to uh gather with any kind of
508
00:20:42,320 --> 00:20:47,440
problem if a user administrator is uh on
509
00:20:45,120 --> 00:20:50,159
holiday or is leaving the company the
510
00:20:47,440 --> 00:20:53,280
other user administrator can take over
511
00:20:50,159 --> 00:20:56,400
the role and can revoke access so it's
512
00:20:53,280 --> 00:20:58,880
important that these concepts are clear
513
00:20:56,400 --> 00:21:01,520
and as i said before
514
00:20:58,880 --> 00:21:03,600
we also have set four party providers as
515
00:21:01,520 --> 00:21:05,440
consultants to
516
00:21:03,600 --> 00:21:07,280
request accessing behalf of your
517
00:21:05,440 --> 00:21:09,919
organization
518
00:21:07,280 --> 00:21:11,120
the they can do it with the their own
519
00:21:09,919 --> 00:21:12,000
business
520
00:21:11,120 --> 00:21:13,919
email
521
00:21:12,000 --> 00:21:15,520
a support is important that you
522
00:21:13,919 --> 00:21:18,480
recognize that they are the right
523
00:21:15,520 --> 00:21:20,480
consultants and even if they want to be
524
00:21:18,480 --> 00:21:22,320
the user administrator it's important
525
00:21:20,480 --> 00:21:24,640
that they provide the right application
526
00:21:22,320 --> 00:21:25,919
letter with the right information so we
527
00:21:24,640 --> 00:21:28,840
can verify
528
00:21:25,919 --> 00:21:31,520
that access is granted to to the right
529
00:21:28,840 --> 00:21:34,640
person all the process with a
530
00:21:31,520 --> 00:21:36,960
step-by-step guide is documented in the
531
00:21:34,640 --> 00:21:37,919
homepage of the ema account management
532
00:21:36,960 --> 00:21:41,760
system
533
00:21:37,919 --> 00:21:44,720
you can find it at register.tama.drop.u
534
00:21:41,760 --> 00:21:46,320
and the homepage will show you
535
00:21:44,720 --> 00:21:48,640
the different functionality of the
536
00:21:46,320 --> 00:21:50,159
system and specifically how to request
537
00:21:48,640 --> 00:21:52,559
access in the
538
00:21:50,159 --> 00:21:55,039
link that we put in the presentation
539
00:21:52,559 --> 00:21:57,120
these are the different roles
540
00:21:55,039 --> 00:21:59,520
that are available for artists in
541
00:21:57,120 --> 00:22:01,919
general and that will be applicable also
542
00:21:59,520 --> 00:22:04,559
for the inspection procedures
543
00:22:01,919 --> 00:22:06,559
as we said the user administrator rule
544
00:22:04,559 --> 00:22:09,360
is a role that
545
00:22:06,559 --> 00:22:10,720
doesn't give access to iris platform
546
00:22:09,360 --> 00:22:12,480
itself
547
00:22:10,720 --> 00:22:13,360
um
548
00:22:12,480 --> 00:22:15,520
but
549
00:22:13,360 --> 00:22:17,200
he grants access only in the m account
550
00:22:15,520 --> 00:22:20,559
management system
551
00:22:17,200 --> 00:22:23,520
so this user will not be able to access
552
00:22:20,559 --> 00:22:26,720
the rs platform unless he requests also
553
00:22:23,520 --> 00:22:29,600
a manager or a contributor role then we
554
00:22:26,720 --> 00:22:32,000
have the rs industry manager that is one
555
00:22:29,600 --> 00:22:34,480
of the main role in the platform
556
00:22:32,000 --> 00:22:37,280
this role has several functionalities so
557
00:22:34,480 --> 00:22:39,919
you will be able to
558
00:22:37,280 --> 00:22:41,280
create delete and delete applications
559
00:22:39,919 --> 00:22:43,600
you will be able
560
00:22:41,280 --> 00:22:46,240
to edit and view only the applications
561
00:22:43,600 --> 00:22:47,360
created by the manager or for which is
562
00:22:46,240 --> 00:22:50,159
appointed
563
00:22:47,360 --> 00:22:52,880
and we also able to
564
00:22:50,159 --> 00:22:56,400
appoint other users like contributors to
565
00:22:52,880 --> 00:22:58,720
participate to the specific procedure
566
00:22:56,400 --> 00:23:01,280
and finally the manager is the one that
567
00:22:58,720 --> 00:23:03,760
is also responsible for submitting the
568
00:23:01,280 --> 00:23:06,640
the application so clicking the final
569
00:23:03,760 --> 00:23:08,720
validation of the of the submission
570
00:23:06,640 --> 00:23:11,600
the address industry contributor is a
571
00:23:08,720 --> 00:23:14,080
limited access can only
572
00:23:11,600 --> 00:23:16,720
edit and view the specific applications
573
00:23:14,080 --> 00:23:18,960
where is invited to contribute but it
574
00:23:16,720 --> 00:23:21,120
cannot submit the application itself so
575
00:23:18,960 --> 00:23:23,039
it's a limited role with the limited
576
00:23:21,120 --> 00:23:26,799
functionalities thank you very much
577
00:23:23,039 --> 00:23:29,520
carlo yes we can read them for you or
578
00:23:26,799 --> 00:23:31,360
how would you like to do it
579
00:23:29,520 --> 00:23:34,559
let's um
580
00:23:31,360 --> 00:23:36,080
see if we can answer them straight away
581
00:23:34,559 --> 00:23:38,240
okay
582
00:23:36,080 --> 00:23:40,880
uh the first thing is how may i change
583
00:23:38,240 --> 00:23:42,080
my username this is unfortunately not
584
00:23:40,880 --> 00:23:43,360
possible
585
00:23:42,080 --> 00:23:45,840
so
586
00:23:43,360 --> 00:23:47,919
we have in our future roadmap to rely
587
00:23:45,840 --> 00:23:52,320
only on emails but uh right now the
588
00:23:47,919 --> 00:23:53,919
username is used and it's not possible
589
00:23:52,320 --> 00:23:55,919
to change the username because it
590
00:23:53,919 --> 00:23:58,480
creates many dependencies also in other
591
00:23:55,919 --> 00:24:00,240
applications so this is not possible at
592
00:23:58,480 --> 00:24:02,480
this point in time the only option that
593
00:24:00,240 --> 00:24:04,960
you have is to register a new
594
00:24:02,480 --> 00:24:07,039
user but uh we discourage this because
595
00:24:04,960 --> 00:24:08,559
this will again create
596
00:24:07,039 --> 00:24:10,480
duplicates uh
597
00:24:08,559 --> 00:24:12,559
in in the platform
598
00:24:10,480 --> 00:24:14,159
carlo we can if you want if it's easier
599
00:24:12,559 --> 00:24:15,919
for you we can read the questions out
600
00:24:14,159 --> 00:24:17,760
loud because we have them in front of us
601
00:24:15,919 --> 00:24:19,600
so we can read them and then we can
602
00:24:17,760 --> 00:24:22,400
answer them together
603
00:24:19,600 --> 00:24:24,880
yeah okay as you prefer yes so the next
604
00:24:22,400 --> 00:24:27,039
question is the following
605
00:24:24,880 --> 00:24:28,960
as an mah would you receive inspection
606
00:24:27,039 --> 00:24:32,720
requests for all organizations
607
00:24:28,960 --> 00:24:35,120
registered under our account
608
00:24:32,720 --> 00:24:37,200
so i would say yes sir this is more an
609
00:24:35,120 --> 00:24:38,960
iris related question
610
00:24:37,200 --> 00:24:42,000
in access
611
00:24:38,960 --> 00:24:44,640
indeed so i'm not sure what is meant by
612
00:24:42,000 --> 00:24:46,559
all the organizations under our account
613
00:24:44,640 --> 00:24:49,840
do you mean um
614
00:24:46,559 --> 00:24:51,120
all the sides with with whom the mah
615
00:24:49,840 --> 00:24:54,799
works because
616
00:24:51,120 --> 00:24:57,840
the idea is that as an mah you are
617
00:24:54,799 --> 00:24:59,919
notified of the inspections related to
618
00:24:57,840 --> 00:25:02,240
the products for which you hold a
619
00:24:59,919 --> 00:25:04,480
marketing authorization i don't know if
620
00:25:02,240 --> 00:25:07,440
this addresses the question but
621
00:25:04,480 --> 00:25:09,520
um what we can do um
622
00:25:07,440 --> 00:25:11,039
is we can elaborate a bit further if the
623
00:25:09,520 --> 00:25:14,480
person who raised this question would
624
00:25:11,039 --> 00:25:16,799
like to to add further details and when
625
00:25:14,480 --> 00:25:19,120
we talk about the products for which you
626
00:25:16,799 --> 00:25:20,880
hold a marketing authorization of course
627
00:25:19,120 --> 00:25:23,840
i'm always talking about centrally
628
00:25:20,880 --> 00:25:26,080
authorized products so iris is limited
629
00:25:23,840 --> 00:25:27,919
to manage inspections for caps we are
630
00:25:26,080 --> 00:25:30,320
not talking here about inspections for
631
00:25:27,919 --> 00:25:32,080
nationally authorized products
632
00:25:30,320 --> 00:25:34,240
next question
633
00:25:32,080 --> 00:25:36,559
if an organization already has an admin
634
00:25:34,240 --> 00:25:38,640
user for iris scientific advice is this
635
00:25:36,559 --> 00:25:40,960
person automatically admin for iris
636
00:25:38,640 --> 00:25:42,400
inspections or is there an additional
637
00:25:40,960 --> 00:25:43,919
step needed
638
00:25:42,400 --> 00:25:46,400
under the same
639
00:25:43,919 --> 00:25:47,600
umbrella the artist administrator can
640
00:25:46,400 --> 00:25:49,840
approve
641
00:25:47,600 --> 00:25:52,240
a request to access the platform for all
642
00:25:49,840 --> 00:25:54,080
the procedures if he's a scientific
643
00:25:52,240 --> 00:25:56,799
advice
644
00:25:54,080 --> 00:25:59,600
or if he's an inspection is everything
645
00:25:56,799 --> 00:26:01,840
under the the same umbrella uh can a
646
00:25:59,600 --> 00:26:03,760
user admin approve another person as a
647
00:26:01,840 --> 00:26:05,840
user admin this will help in case of
648
00:26:03,760 --> 00:26:07,600
people being out of office or leaving an
649
00:26:05,840 --> 00:26:09,840
organization
650
00:26:07,600 --> 00:26:10,799
exactly yes and this is what we advise
651
00:26:09,840 --> 00:26:13,760
to do
652
00:26:10,799 --> 00:26:16,159
to have more than one user administrator
653
00:26:13,760 --> 00:26:18,960
as i said before only the first one is
654
00:26:16,159 --> 00:26:21,120
appointed by the ema all the other ones
655
00:26:18,960 --> 00:26:23,039
are approved by the the user
656
00:26:21,120 --> 00:26:25,279
administrators available for that
657
00:26:23,039 --> 00:26:26,159
organization so
658
00:26:25,279 --> 00:26:28,400
we
659
00:26:26,159 --> 00:26:29,919
strongly encourage to to have more than
660
00:26:28,400 --> 00:26:32,080
one
661
00:26:29,919 --> 00:26:35,120
the next question is do you need an iris
662
00:26:32,080 --> 00:26:37,120
manager role for multiple entities and
663
00:26:35,120 --> 00:26:39,840
so do you need to apply for each entity
664
00:26:37,120 --> 00:26:39,840
separately
665
00:26:40,080 --> 00:26:46,000
yes it depends on the regulatory
666
00:26:42,640 --> 00:26:46,960
entitlements where they are sitting
667
00:26:46,000 --> 00:26:49,520
so
668
00:26:46,960 --> 00:26:51,360
in case there are multiple organizations
669
00:26:49,520 --> 00:26:54,159
in different countries you will need to
670
00:26:51,360 --> 00:26:56,640
apply differently for each organization
671
00:26:54,159 --> 00:26:58,640
all right um we can see there are other
672
00:26:56,640 --> 00:27:00,480
questions but i think they are not so
673
00:26:58,640 --> 00:27:01,840
much linked to access management maybe
674
00:27:00,480 --> 00:27:04,480
they are more
675
00:27:01,840 --> 00:27:08,240
uh related to the the way iris will be
676
00:27:04,480 --> 00:27:10,400
working so i would propose that we
677
00:27:08,240 --> 00:27:12,559
answer them at the end
678
00:27:10,400 --> 00:27:14,559
and if there is anything else related to
679
00:27:12,559 --> 00:27:16,320
access management please feel free to
680
00:27:14,559 --> 00:27:18,159
write it in the chat and as i said we
681
00:27:16,320 --> 00:27:20,399
will compile all the questions and we
682
00:27:18,159 --> 00:27:22,880
can liaise with carlo to come back to
683
00:27:20,399 --> 00:27:25,279
you and give you an answer
684
00:27:22,880 --> 00:27:27,440
so carlo thank you very much for your
685
00:27:25,279 --> 00:27:30,880
presentation and for explaining the
686
00:27:27,440 --> 00:27:33,600
different access roles in iris thank you
687
00:27:30,880 --> 00:27:35,679
so we're gonna move on now to the next
688
00:27:33,600 --> 00:27:39,520
section of the presentation
689
00:27:35,679 --> 00:27:42,720
which talks about the planned go lives
690
00:27:39,520 --> 00:27:45,120
and you can see on the screen that we
691
00:27:42,720 --> 00:27:47,039
have a timeline
692
00:27:45,120 --> 00:27:48,960
that goes back to april but i have to
693
00:27:47,039 --> 00:27:51,840
say that actually this project started
694
00:27:48,960 --> 00:27:54,240
much earlier we already started in 2020
695
00:27:51,840 --> 00:27:55,120
um a bit before the summer
696
00:27:54,240 --> 00:27:57,600
um
697
00:27:55,120 --> 00:27:59,600
gathering requirements and setting up
698
00:27:57,600 --> 00:28:01,279
the project team
699
00:27:59,600 --> 00:28:03,440
and setting up the the colleagues who
700
00:28:01,279 --> 00:28:04,559
will be contributing
701
00:28:03,440 --> 00:28:06,640
and
702
00:28:04,559 --> 00:28:08,159
development started already towards the
703
00:28:06,640 --> 00:28:10,399
end of last year
704
00:28:08,159 --> 00:28:11,279
and then at the beginning of this year
705
00:28:10,399 --> 00:28:13,600
we
706
00:28:11,279 --> 00:28:17,039
started working on our change management
707
00:28:13,600 --> 00:28:20,720
strategy our change management plan
708
00:28:17,039 --> 00:28:23,840
you might know that we established
709
00:28:20,720 --> 00:28:27,279
an industry volunteer group and and also
710
00:28:23,840 --> 00:28:29,520
we did the same for um
711
00:28:27,279 --> 00:28:32,559
nca's for inspectors
712
00:28:29,520 --> 00:28:34,799
so this was very helpful for us and and
713
00:28:32,559 --> 00:28:37,120
i want to thank
714
00:28:34,799 --> 00:28:40,000
publicly the the colleagues who who were
715
00:28:37,120 --> 00:28:41,120
put forward because their input was
716
00:28:40,000 --> 00:28:43,840
um
717
00:28:41,120 --> 00:28:46,240
very useful for us to to focus on what
718
00:28:43,840 --> 00:28:48,480
we needed to clarify further and to
719
00:28:46,240 --> 00:28:50,799
explain areas where perhaps there was a
720
00:28:48,480 --> 00:28:50,799
bit of
721
00:28:51,679 --> 00:28:55,520
a bit of lack of clarity
722
00:28:54,080 --> 00:28:57,679
and
723
00:28:55,520 --> 00:28:59,279
these chain champions groups as i said
724
00:28:57,679 --> 00:29:01,679
we had
725
00:28:59,279 --> 00:29:03,039
them for industry volunteers and also
726
00:29:01,679 --> 00:29:05,440
for inspectors
727
00:29:03,039 --> 00:29:08,320
we kicked them off in may and june so
728
00:29:05,440 --> 00:29:10,720
you see that in may we had the kickoff
729
00:29:08,320 --> 00:29:13,760
webinar with the inspectors chain
730
00:29:10,720 --> 00:29:15,200
champions and then a bit later in june
731
00:29:13,760 --> 00:29:17,679
towards the end of june beginning of
732
00:29:15,200 --> 00:29:19,919
july we had the kickoff webinar with
733
00:29:17,679 --> 00:29:21,120
industry chain champions
734
00:29:19,919 --> 00:29:23,200
since then
735
00:29:21,120 --> 00:29:25,279
we've been quite busy every month
736
00:29:23,200 --> 00:29:26,880
because we wanted to have at least one
737
00:29:25,279 --> 00:29:29,120
monthly meeting which
738
00:29:26,880 --> 00:29:30,880
with each of these groups
739
00:29:29,120 --> 00:29:33,039
to be able to show
740
00:29:30,880 --> 00:29:35,919
how we were developing the system so
741
00:29:33,039 --> 00:29:38,480
that they could start getting familiar
742
00:29:35,919 --> 00:29:40,720
with it ask their questions and also
743
00:29:38,480 --> 00:29:42,880
raise concerns that they may
744
00:29:40,720 --> 00:29:46,080
had at the time so that we could address
745
00:29:42,880 --> 00:29:46,080
them before going live
746
00:29:46,159 --> 00:29:50,159
and then
747
00:29:47,200 --> 00:29:51,039
we are at the point um
748
00:29:50,159 --> 00:29:52,399
where
749
00:29:51,039 --> 00:29:53,600
if you can see in the screen in
750
00:29:52,399 --> 00:29:55,600
september
751
00:29:53,600 --> 00:29:57,440
where we are running a series of
752
00:29:55,600 --> 00:29:59,600
training sessions
753
00:29:57,440 --> 00:30:01,840
this week i have to say has been very
754
00:29:59,600 --> 00:30:03,039
hectic because we've been running a
755
00:30:01,840 --> 00:30:04,720
number of
756
00:30:03,039 --> 00:30:06,559
sessions
757
00:30:04,720 --> 00:30:08,880
not only for
758
00:30:06,559 --> 00:30:10,880
internal stakeholders at ema but also
759
00:30:08,880 --> 00:30:13,520
for external stakeholders so yesterday
760
00:30:10,880 --> 00:30:16,159
we had a session with gmp and gcp
761
00:30:13,520 --> 00:30:18,799
inspectors and today we are having this
762
00:30:16,159 --> 00:30:21,360
industry training focusing very much on
763
00:30:18,799 --> 00:30:24,080
gmp and gcp
764
00:30:21,360 --> 00:30:26,559
we are also planning um subsequent
765
00:30:24,080 --> 00:30:28,880
training sessions there is one planned
766
00:30:26,559 --> 00:30:31,520
for next week that is
767
00:30:28,880 --> 00:30:32,960
addressing committee members
768
00:30:31,520 --> 00:30:36,000
and then
769
00:30:32,960 --> 00:30:38,320
once we go live with or ahead of the go
770
00:30:36,000 --> 00:30:41,440
live for pharmacovigilance we will have
771
00:30:38,320 --> 00:30:44,320
a dedicated session with inspectors on
772
00:30:41,440 --> 00:30:46,080
pharmacovigilance inspections and also
773
00:30:44,320 --> 00:30:48,960
you will hear from us because we will
774
00:30:46,080 --> 00:30:51,360
organize a training session for industry
775
00:30:48,960 --> 00:30:53,039
users focused on pharmacovigilance
776
00:30:51,360 --> 00:30:54,240
inspections
777
00:30:53,039 --> 00:30:55,520
so
778
00:30:54,240 --> 00:30:57,679
this is
779
00:30:55,520 --> 00:30:59,679
related to training
780
00:30:57,679 --> 00:31:01,919
but of course together with all these
781
00:30:59,679 --> 00:31:05,360
training sessions we also have a lot of
782
00:31:01,919 --> 00:31:06,799
communication so we are working now on
783
00:31:05,360 --> 00:31:09,279
preparing
784
00:31:06,799 --> 00:31:10,240
the communications for the go lives
785
00:31:09,279 --> 00:31:12,080
um
786
00:31:10,240 --> 00:31:14,640
also
787
00:31:12,080 --> 00:31:16,880
we we will have some features in the
788
00:31:14,640 --> 00:31:19,919
iris newsletters as i said the iris
789
00:31:16,880 --> 00:31:22,159
forums we will publish
790
00:31:19,919 --> 00:31:25,600
the relevant announcements on the ema
791
00:31:22,159 --> 00:31:27,840
website so that you can
792
00:31:25,600 --> 00:31:28,960
keep up to date with when we're going
793
00:31:27,840 --> 00:31:30,960
live
794
00:31:28,960 --> 00:31:32,880
and speaking of
795
00:31:30,960 --> 00:31:34,640
going live
796
00:31:32,880 --> 00:31:37,279
i have to say that
797
00:31:34,640 --> 00:31:39,200
um initially the the plan go live for
798
00:31:37,279 --> 00:31:40,960
gmp
799
00:31:39,200 --> 00:31:43,840
was next monday
800
00:31:40,960 --> 00:31:44,640
13th um this was our aimed
801
00:31:43,840 --> 00:31:46,559
but
802
00:31:44,640 --> 00:31:49,039
very recently we've learned that we will
803
00:31:46,559 --> 00:31:51,120
need to postpone it for a few days so
804
00:31:49,039 --> 00:31:52,240
most likely we will go live the week
805
00:31:51,120 --> 00:31:54,320
after
806
00:31:52,240 --> 00:31:55,919
so still in september but a few days
807
00:31:54,320 --> 00:32:00,399
afterwards
808
00:31:55,919 --> 00:32:02,960
for gcp we have identity go go live of
809
00:32:00,399 --> 00:32:05,440
end of the this month
810
00:32:02,960 --> 00:32:08,080
but again depending on how things are
811
00:32:05,440 --> 00:32:11,760
progressing we might be late slightly
812
00:32:08,080 --> 00:32:13,919
for a few days and go live in october
813
00:32:11,760 --> 00:32:17,120
for pharmacovigilance i cannot give you
814
00:32:13,919 --> 00:32:19,440
a specific month because
815
00:32:17,120 --> 00:32:22,320
development is still
816
00:32:19,440 --> 00:32:24,080
in a very early stage but as soon as we
817
00:32:22,320 --> 00:32:26,720
have more information and we are a bit
818
00:32:24,080 --> 00:32:28,480
more advanced we will let you know when
819
00:32:26,720 --> 00:32:29,840
pharmacovigilance inspections will be
820
00:32:28,480 --> 00:32:33,600
onboarded
821
00:32:29,840 --> 00:32:34,960
and i would like now to focus on gmp
822
00:32:33,600 --> 00:32:36,880
and give you an overview of the
823
00:32:34,960 --> 00:32:40,480
high-level business process that we will
824
00:32:36,880 --> 00:32:42,240
be following in iris for gmp inspections
825
00:32:40,480 --> 00:32:45,279
you will see that even though it says
826
00:32:42,240 --> 00:32:47,039
dmp workflow when we talk about gcp it's
827
00:32:45,279 --> 00:32:47,760
not so different
828
00:32:47,039 --> 00:32:50,880
but
829
00:32:47,760 --> 00:32:54,159
we thought it's better to go through it
830
00:32:50,880 --> 00:32:57,360
step by step and and then repeat it for
831
00:32:54,159 --> 00:32:59,760
gcp explaining what the differences are
832
00:32:57,360 --> 00:33:01,919
so the workflow as i mentioned earlier
833
00:32:59,760 --> 00:33:04,320
will start with the creation of a case
834
00:33:01,919 --> 00:33:06,960
with a gmp inspection case
835
00:33:04,320 --> 00:33:09,600
and as i said earlier these will be
836
00:33:06,960 --> 00:33:11,760
triggered by ema so industry users do
837
00:33:09,600 --> 00:33:14,399
not need to trigger anything don't need
838
00:33:11,760 --> 00:33:16,000
to create any submission
839
00:33:14,399 --> 00:33:18,880
we at ema
840
00:33:16,000 --> 00:33:21,519
we will create the inspection request
841
00:33:18,880 --> 00:33:23,440
and we will take all the necessary steps
842
00:33:21,519 --> 00:33:25,679
to make sure that that inspection is
843
00:33:23,440 --> 00:33:27,840
adopted by the relevant committee so
844
00:33:25,679 --> 00:33:30,480
chmp in the case of human medicinal
845
00:33:27,840 --> 00:33:32,000
products and cvmp for veterinary
846
00:33:30,480 --> 00:33:33,760
products
847
00:33:32,000 --> 00:33:35,600
once the inspection is adopted by the
848
00:33:33,760 --> 00:33:37,760
committee
849
00:33:35,600 --> 00:33:39,279
you will receive a notification and we
850
00:33:37,760 --> 00:33:41,039
will talk a bit more about this
851
00:33:39,279 --> 00:33:43,679
notification
852
00:33:41,039 --> 00:33:45,840
this will prompt you
853
00:33:43,679 --> 00:33:47,760
to know that something has been
854
00:33:45,840 --> 00:33:49,200
requested for a product for which your
855
00:33:47,760 --> 00:33:51,200
company holds
856
00:33:49,200 --> 00:33:54,080
the marketing authorization
857
00:33:51,200 --> 00:33:56,720
and these will also provide you
858
00:33:54,080 --> 00:33:59,200
with the ability to go through the
859
00:33:56,720 --> 00:34:00,080
portal once you are an idis registered
860
00:33:59,200 --> 00:34:02,720
user
861
00:34:00,080 --> 00:34:04,320
go through the industry portal and view
862
00:34:02,720 --> 00:34:06,080
all the details related to that
863
00:34:04,320 --> 00:34:08,240
inspection
864
00:34:06,080 --> 00:34:10,720
at this point
865
00:34:08,240 --> 00:34:13,040
you also have the possibility to enter
866
00:34:10,720 --> 00:34:16,320
the po number so the purchase order
867
00:34:13,040 --> 00:34:18,399
number via the portal so in the current
868
00:34:16,320 --> 00:34:20,079
process you
869
00:34:18,399 --> 00:34:22,000
we used to request that you would
870
00:34:20,079 --> 00:34:23,839
provide this to us
871
00:34:22,000 --> 00:34:26,240
and normally this will be done by an
872
00:34:23,839 --> 00:34:28,399
email but now you don't need to send us
873
00:34:26,240 --> 00:34:31,040
an email there is a specific field in
874
00:34:28,399 --> 00:34:32,240
ids which allows you to enter the po
875
00:34:31,040 --> 00:34:34,560
number
876
00:34:32,240 --> 00:34:38,000
and i want to highlight the importance
877
00:34:34,560 --> 00:34:40,159
of providing this information to ema
878
00:34:38,000 --> 00:34:41,839
because this is very much linked to the
879
00:34:40,159 --> 00:34:45,200
financial procedure
880
00:34:41,839 --> 00:34:48,240
so it speeds up the process and also
881
00:34:45,200 --> 00:34:50,480
helps us to make sure
882
00:34:48,240 --> 00:34:52,560
we have the correct information
883
00:34:50,480 --> 00:34:54,720
for that particular inspection what will
884
00:34:52,560 --> 00:34:57,200
happen after inspection the inspection
885
00:34:54,720 --> 00:34:59,599
is adopted is that we will start all the
886
00:34:57,200 --> 00:35:03,920
preparatory work to actually conduct the
887
00:34:59,599 --> 00:35:06,079
inspection and as you probably know
888
00:35:03,920 --> 00:35:09,280
one of the main responsibilities that we
889
00:35:06,079 --> 00:35:10,160
have here at this point is to confirm
890
00:35:09,280 --> 00:35:12,560
that
891
00:35:10,160 --> 00:35:14,160
any inspector who is participating in an
892
00:35:12,560 --> 00:35:16,480
ema inspection
893
00:35:14,160 --> 00:35:18,960
does not have a conflict of interest
894
00:35:16,480 --> 00:35:22,160
so we have a policy and a procedure at
895
00:35:18,960 --> 00:35:24,079
ema where we check for each inspector
896
00:35:22,160 --> 00:35:26,480
involved in an inspection regardless of
897
00:35:24,079 --> 00:35:29,359
the type of inspection we check their
898
00:35:26,480 --> 00:35:31,599
declaration of interest and we confirm
899
00:35:29,359 --> 00:35:33,440
that indeed it is accordance in
900
00:35:31,599 --> 00:35:36,000
accordance with our policy and that the
901
00:35:33,440 --> 00:35:38,400
inspectors are approved to participate
902
00:35:36,000 --> 00:35:40,560
once that is done the inspection will be
903
00:35:38,400 --> 00:35:42,560
scheduled we will be notified by the
904
00:35:40,560 --> 00:35:43,599
inspectors when the inspection is taking
905
00:35:42,560 --> 00:35:45,520
place
906
00:35:43,599 --> 00:35:48,320
you know what happens next the
907
00:35:45,520 --> 00:35:49,359
inspection is actually happening and
908
00:35:48,320 --> 00:35:51,440
there is
909
00:35:49,359 --> 00:35:53,599
the interaction between the inspection
910
00:35:51,440 --> 00:35:57,359
team and the inspecting
911
00:35:53,599 --> 00:35:59,200
at the end of of the inspection
912
00:35:57,359 --> 00:36:01,280
there is this closing meeting and after
913
00:35:59,200 --> 00:36:02,640
that the inspect the inspection team
914
00:36:01,280 --> 00:36:04,560
would go back
915
00:36:02,640 --> 00:36:07,440
to put together a draft inspection
916
00:36:04,560 --> 00:36:08,240
report that is provided to the inspectee
917
00:36:07,440 --> 00:36:10,079
um
918
00:36:08,240 --> 00:36:12,000
so that the inspector has the chance to
919
00:36:10,079 --> 00:36:13,920
read it and address any deficiencies
920
00:36:12,000 --> 00:36:16,480
that have been identified
921
00:36:13,920 --> 00:36:18,800
once the responses from the inspectee
922
00:36:16,480 --> 00:36:21,040
have been received by the inspect
923
00:36:18,800 --> 00:36:24,800
inspection team they will finalize the
924
00:36:21,040 --> 00:36:26,400
inspection report and provide it to ema
925
00:36:24,800 --> 00:36:29,440
once ema receives
926
00:36:26,400 --> 00:36:32,079
that inspection report we will put in
927
00:36:29,440 --> 00:36:34,880
iris when we have received a report
928
00:36:32,079 --> 00:36:37,200
whether the report is valid
929
00:36:34,880 --> 00:36:39,839
um whether there is a clear conclusion
930
00:36:37,200 --> 00:36:43,040
of the report so for example if it's a
931
00:36:39,839 --> 00:36:44,800
gmp inspection is the site gmp compliant
932
00:36:43,040 --> 00:36:47,200
or not
933
00:36:44,800 --> 00:36:50,000
any um additional information that the
934
00:36:47,200 --> 00:36:51,920
inspectors want to flag to us and also
935
00:36:50,000 --> 00:36:53,760
when is the next inspection so the
936
00:36:51,920 --> 00:36:56,720
reinspection date
937
00:36:53,760 --> 00:36:57,599
once of all that is clear
938
00:36:56,720 --> 00:36:59,440
then
939
00:36:57,599 --> 00:37:01,760
we will proceed with the finalization of
940
00:36:59,440 --> 00:37:04,400
the case and you will be notified that
941
00:37:01,760 --> 00:37:06,160
the case has been closed
942
00:37:04,400 --> 00:37:08,560
one thing i want to highlight here is
943
00:37:06,160 --> 00:37:10,320
the the
944
00:37:08,560 --> 00:37:14,000
note that you have
945
00:37:10,320 --> 00:37:14,000
on the right hand side at the bottom
946
00:37:14,480 --> 00:37:19,119
where it says that the received of the
947
00:37:16,800 --> 00:37:22,000
inspection report at ema so when we
948
00:37:19,119 --> 00:37:25,200
receive the report from the inspectors
949
00:37:22,000 --> 00:37:27,920
this triggers the financial workflow and
950
00:37:25,200 --> 00:37:30,240
i want to highlight this because this is
951
00:37:27,920 --> 00:37:32,000
new compared to the current process in
952
00:37:30,240 --> 00:37:34,960
the current process
953
00:37:32,000 --> 00:37:36,480
the invoice to the applicant
954
00:37:34,960 --> 00:37:39,119
was sent
955
00:37:36,480 --> 00:37:41,440
on the first day of the inspection
956
00:37:39,119 --> 00:37:42,960
this is not not going to happen anymore
957
00:37:41,440 --> 00:37:45,839
with ids
958
00:37:42,960 --> 00:37:48,240
the invoice to the mih to the applicant
959
00:37:45,839 --> 00:37:49,680
will be sent at the time we receive the
960
00:37:48,240 --> 00:37:52,560
inspection report
961
00:37:49,680 --> 00:37:54,000
so if you wonder oh there are some
962
00:37:52,560 --> 00:37:55,760
inspections that are all they are
963
00:37:54,000 --> 00:37:57,760
ongoing they are
964
00:37:55,760 --> 00:37:58,480
managing the old system i'm receiving
965
00:37:57,760 --> 00:38:01,520
the
966
00:37:58,480 --> 00:38:03,680
invoice at the time of the start of the
967
00:38:01,520 --> 00:38:06,400
inspection and but this is not in line
968
00:38:03,680 --> 00:38:08,560
with iris you know why with iris we are
969
00:38:06,400 --> 00:38:11,760
changing this practice and you will
970
00:38:08,560 --> 00:38:14,800
receive the invoice later in the process
971
00:38:11,760 --> 00:38:16,800
and now um i'm going to hand over to my
972
00:38:14,800 --> 00:38:19,839
colleague miguel who is going to take
973
00:38:16,800 --> 00:38:22,320
you through the gcp business process so
974
00:38:19,839 --> 00:38:24,320
miguel over to you
975
00:38:22,320 --> 00:38:27,200
well hello everybody and thank you very
976
00:38:24,320 --> 00:38:28,320
much for for attending this training i
977
00:38:27,200 --> 00:38:30,160
assessed
978
00:38:28,320 --> 00:38:33,599
already presented my name is miguel
979
00:38:30,160 --> 00:38:34,800
rodriguez and i'm the gcp subject matter
980
00:38:33,599 --> 00:38:36,960
expert
981
00:38:34,800 --> 00:38:39,359
and i would like to introduce you to the
982
00:38:36,960 --> 00:38:41,119
business process for gcp even if there
983
00:38:39,359 --> 00:38:43,839
is not so much difference compared to
984
00:38:41,119 --> 00:38:46,160
the gmp but um so i will not repeat
985
00:38:43,839 --> 00:38:48,160
myself i will not repeat what ester has
986
00:38:46,160 --> 00:38:50,800
already said i will just highlight what
987
00:38:48,160 --> 00:38:52,640
are the differences between gmp and gcp
988
00:38:50,800 --> 00:38:54,960
so as you can see the steps are more or
989
00:38:52,640 --> 00:38:57,839
less the same so
990
00:38:54,960 --> 00:39:00,560
for gcp we will start creating the the
991
00:38:57,839 --> 00:39:04,079
gcp case once it has identified
992
00:39:00,560 --> 00:39:06,480
identified a need for a for an gcp
993
00:39:04,079 --> 00:39:09,280
inspection routine or trigger
994
00:39:06,480 --> 00:39:10,079
and we will be working on deciding on
995
00:39:09,280 --> 00:39:12,839
the
996
00:39:10,079 --> 00:39:15,520
clinical trial and the sites to be
997
00:39:12,839 --> 00:39:17,599
inspected and obviously that will be
998
00:39:15,520 --> 00:39:18,880
done
999
00:39:17,599 --> 00:39:21,119
in-house
1000
00:39:18,880 --> 00:39:23,440
then once once the
1001
00:39:21,119 --> 00:39:24,720
the request has been adopted by the chnp
1002
00:39:23,440 --> 00:39:26,320
automatically you will get a
1003
00:39:24,720 --> 00:39:29,040
notification
1004
00:39:26,320 --> 00:39:30,960
and as i understand and uh estelle will
1005
00:39:29,040 --> 00:39:32,720
clarify this notification will go to the
1006
00:39:30,960 --> 00:39:35,839
contract person for the
1007
00:39:32,720 --> 00:39:38,160
for the application or mah
1008
00:39:35,839 --> 00:39:40,240
in there uh similar to the announcement
1009
00:39:38,160 --> 00:39:41,680
letters that we send at the moment
1010
00:39:40,240 --> 00:39:44,320
but we will not send them in the future
1011
00:39:41,680 --> 00:39:46,400
you just get a notification we will ask
1012
00:39:44,320 --> 00:39:48,560
you to provide some documentations to
1013
00:39:46,400 --> 00:39:52,400
emea and to the inspectors
1014
00:39:48,560 --> 00:39:56,880
the documentation and data to emea
1015
00:39:52,400 --> 00:39:58,400
it will go through iris so those are
1016
00:39:56,880 --> 00:40:00,079
the po number
1017
00:39:58,400 --> 00:40:02,160
and some other documentation like the
1018
00:40:00,079 --> 00:40:04,960
acceptance of the inspection
1019
00:40:02,160 --> 00:40:07,359
and the permission for the mah the to
1020
00:40:04,960 --> 00:40:09,359
receive the inspection report
1021
00:40:07,359 --> 00:40:11,440
from the sponsor if applicable
1022
00:40:09,359 --> 00:40:13,760
those ones that will go to emem through
1023
00:40:11,440 --> 00:40:15,040
iris and the rest the ones for the
1024
00:40:13,760 --> 00:40:16,720
inspectors
1025
00:40:15,040 --> 00:40:18,800
uh
1026
00:40:16,720 --> 00:40:20,720
they will need to go to the inspectors
1027
00:40:18,800 --> 00:40:22,640
and you can discuss with them how to
1028
00:40:20,720 --> 00:40:24,880
receive it at the moment we will follow
1029
00:40:22,640 --> 00:40:27,040
then the procedure that we follow at the
1030
00:40:24,880 --> 00:40:30,800
moment that's uh
1031
00:40:27,040 --> 00:40:32,079
by cd or cd-rom or the usb as you have
1032
00:40:30,800 --> 00:40:34,079
been doing
1033
00:40:32,079 --> 00:40:36,720
normally we check the the device of the
1034
00:40:34,079 --> 00:40:39,280
inspectors before we adopt an inspection
1035
00:40:36,720 --> 00:40:41,599
but just in case there has been a later
1036
00:40:39,280 --> 00:40:43,040
addition i have included this step
1037
00:40:41,599 --> 00:40:44,880
uh later on
1038
00:40:43,040 --> 00:40:46,640
one thing that we need to explain is
1039
00:40:44,880 --> 00:40:48,240
that this you will get a notification
1040
00:40:46,640 --> 00:40:50,160
every time that there is a change to the
1041
00:40:48,240 --> 00:40:53,359
to the to the request for the inspection
1042
00:40:50,160 --> 00:40:55,280
so if we add a new site for any reasons
1043
00:40:53,359 --> 00:40:56,960
it will remove one side if we add a
1044
00:40:55,280 --> 00:40:59,119
clinical trial
1045
00:40:56,960 --> 00:41:00,880
you will get a notification we change
1046
00:40:59,119 --> 00:41:02,640
the the date of the
1047
00:41:00,880 --> 00:41:04,319
deadline for the integrated inspection
1048
00:41:02,640 --> 00:41:07,599
report
1049
00:41:04,319 --> 00:41:10,160
for like for gmp uh the process for for
1050
00:41:07,599 --> 00:41:11,760
the inspection will go on and the
1051
00:41:10,160 --> 00:41:12,960
inspectors will be responsible to
1052
00:41:11,760 --> 00:41:15,200
contact the
1053
00:41:12,960 --> 00:41:17,839
the applicant and to ask for contacts
1054
00:41:15,200 --> 00:41:20,079
for the inspectors and any coordinator
1055
00:41:17,839 --> 00:41:22,960
for the for the inspection and that will
1056
00:41:20,079 --> 00:41:24,960
take place outside iris unless uh is
1057
00:41:22,960 --> 00:41:27,119
decided by the inspectors to do it
1058
00:41:24,960 --> 00:41:28,400
through iris but in principle it will be
1059
00:41:27,119 --> 00:41:30,480
outside
1060
00:41:28,400 --> 00:41:32,000
and once everything has been done all
1061
00:41:30,480 --> 00:41:34,319
the communication with the
1062
00:41:32,000 --> 00:41:36,640
inspectors the responses to the to the
1063
00:41:34,319 --> 00:41:38,640
inspection report and the finalization
1064
00:41:36,640 --> 00:41:41,040
of the integrated inspection report the
1065
00:41:38,640 --> 00:41:42,400
inspectors are responsible to upload
1066
00:41:41,040 --> 00:41:45,200
that document
1067
00:41:42,400 --> 00:41:46,319
uh to the irs
1068
00:41:45,200 --> 00:41:48,880
platform
1069
00:41:46,319 --> 00:41:51,920
our cmea coordinators we will
1070
00:41:48,880 --> 00:41:54,880
check that documentation is complete and
1071
00:41:51,920 --> 00:41:56,960
as it was for gmp we will
1072
00:41:54,880 --> 00:41:58,319
issue the
1073
00:41:56,960 --> 00:42:00,960
the invoice
1074
00:41:58,319 --> 00:42:02,880
and the payments for the inspectors once
1075
00:42:00,960 --> 00:42:04,800
everything has been validated
1076
00:42:02,880 --> 00:42:08,880
and you will get a notification that the
1077
00:42:04,800 --> 00:42:11,680
ins the the the process has finalized
1078
00:42:08,880 --> 00:42:13,920
as i said at the beginning the
1079
00:42:11,680 --> 00:42:14,960
if we have the permission to to share
1080
00:42:13,920 --> 00:42:16,560
the
1081
00:42:14,960 --> 00:42:19,440
integrated inspection report with the
1082
00:42:16,560 --> 00:42:20,640
applicant we will do so at this point
1083
00:42:19,440 --> 00:42:22,160
and i think
1084
00:42:20,640 --> 00:42:24,079
i just highlighted the differences
1085
00:42:22,160 --> 00:42:26,160
everything else will be very similar to
1086
00:42:24,079 --> 00:42:28,480
the mp
1087
00:42:26,160 --> 00:42:30,720
thanks very much miguel thank you for
1088
00:42:28,480 --> 00:42:33,119
flagging those differences
1089
00:42:30,720 --> 00:42:34,160
so now colleagues i would like to move
1090
00:42:33,119 --> 00:42:35,760
on
1091
00:42:34,160 --> 00:42:37,520
to talk a bit more in detail about
1092
00:42:35,760 --> 00:42:39,920
notifications
1093
00:42:37,520 --> 00:42:42,960
and so we've mentioned throughout the
1094
00:42:39,920 --> 00:42:46,800
presentation what is changing but i want
1095
00:42:42,960 --> 00:42:48,400
to repeat once again in practice what um
1096
00:42:46,800 --> 00:42:49,920
modifications you will see in the
1097
00:42:48,400 --> 00:42:51,040
process so
1098
00:42:49,920 --> 00:42:52,960
um
1099
00:42:51,040 --> 00:42:54,880
you might be familiar with the way we
1100
00:42:52,960 --> 00:42:57,040
communicate the announcement of
1101
00:42:54,880 --> 00:43:00,240
inspections at the moment and in the
1102
00:42:57,040 --> 00:43:02,400
asses process what ema does is
1103
00:43:00,240 --> 00:43:04,240
we create two sets of inspection
1104
00:43:02,400 --> 00:43:05,520
correspondence at the beginning of the
1105
00:43:04,240 --> 00:43:08,960
process so
1106
00:43:05,520 --> 00:43:10,720
one set of inspections goes to the
1107
00:43:08,960 --> 00:43:13,200
applicant
1108
00:43:10,720 --> 00:43:16,560
and the other set of inspections
1109
00:43:13,200 --> 00:43:17,440
of correspondence go to the mah
1110
00:43:16,560 --> 00:43:18,960
um
1111
00:43:17,440 --> 00:43:22,319
what happens is that every time that
1112
00:43:18,960 --> 00:43:24,400
something changes we need to make
1113
00:43:22,319 --> 00:43:27,119
changes to the letters and resend them
1114
00:43:24,400 --> 00:43:28,800
with ids this will change because
1115
00:43:27,119 --> 00:43:30,880
we will move away from letters there
1116
00:43:28,800 --> 00:43:33,040
will not be any letters because all the
1117
00:43:30,880 --> 00:43:34,720
information will be up to date in the
1118
00:43:33,040 --> 00:43:37,040
portal and you will access it through
1119
00:43:34,720 --> 00:43:39,200
the industry portal essentially what
1120
00:43:37,040 --> 00:43:41,839
will happen is that we will have
1121
00:43:39,200 --> 00:43:44,319
no more inspection correspondence being
1122
00:43:41,839 --> 00:43:45,760
sent by utrelink
1123
00:43:44,319 --> 00:43:48,880
you will receive
1124
00:43:45,760 --> 00:43:50,400
an email that prompts you to log into
1125
00:43:48,880 --> 00:43:52,880
the iris
1126
00:43:50,400 --> 00:43:55,280
industry portal and in the portal you
1127
00:43:52,880 --> 00:43:57,200
can see all the information related to
1128
00:43:55,280 --> 00:44:00,160
the inspection
1129
00:43:57,200 --> 00:44:03,200
what you can see on this slide is
1130
00:44:00,160 --> 00:44:04,960
the types of notifications that you will
1131
00:44:03,200 --> 00:44:07,280
receive and when i say that you will
1132
00:44:04,960 --> 00:44:09,520
receive i always mean
1133
00:44:07,280 --> 00:44:11,680
the contact point
1134
00:44:09,520 --> 00:44:14,079
for the applicant or mah for that
1135
00:44:11,680 --> 00:44:17,040
particular product so
1136
00:44:14,079 --> 00:44:18,880
at ema as you know for each product we
1137
00:44:17,040 --> 00:44:21,599
have a person
1138
00:44:18,880 --> 00:44:24,319
who is nominated formally to communicate
1139
00:44:21,599 --> 00:44:26,000
on behalf of the applicant or mah and
1140
00:44:24,319 --> 00:44:28,240
this is the contact that will receive
1141
00:44:26,000 --> 00:44:30,720
the notification so you will need to
1142
00:44:28,240 --> 00:44:32,880
make sure that those contacts are
1143
00:44:30,720 --> 00:44:35,119
actually um
1144
00:44:32,880 --> 00:44:37,920
have actually access to iris because
1145
00:44:35,119 --> 00:44:39,760
otherwise they will receive an email but
1146
00:44:37,920 --> 00:44:41,760
when they log in when they try to log
1147
00:44:39,760 --> 00:44:44,240
into iris they will not be able to
1148
00:44:41,760 --> 00:44:46,079
access so very important that julia is
1149
00:44:44,240 --> 00:44:48,160
with your colleagues who are
1150
00:44:46,079 --> 00:44:50,160
at the moment
1151
00:44:48,160 --> 00:44:52,720
nominated as contact points for
1152
00:44:50,160 --> 00:44:55,440
centrally authorized products
1153
00:44:52,720 --> 00:44:57,440
and that you start requesting access for
1154
00:44:55,440 --> 00:44:59,440
ids to these colleagues these colleagues
1155
00:44:57,440 --> 00:45:02,800
will receive a notification that an
1156
00:44:59,440 --> 00:45:04,880
inspection has been requested by ema for
1157
00:45:02,800 --> 00:45:07,680
for their products and
1158
00:45:04,880 --> 00:45:11,520
you as i said you would be asked to
1159
00:45:07,680 --> 00:45:13,980
login to the system to view the details
1160
00:45:11,520 --> 00:45:15,520
then if for whatever reason
1161
00:45:13,980 --> 00:45:17,440
[Music]
1162
00:45:15,520 --> 00:45:19,280
we
1163
00:45:17,440 --> 00:45:22,800
cancel the inspection of the inspection
1164
00:45:19,280 --> 00:45:25,599
is cancelled and this happens after the
1165
00:45:22,800 --> 00:45:27,359
committee has adopted the inspection
1166
00:45:25,599 --> 00:45:30,240
then of course the industry will be
1167
00:45:27,359 --> 00:45:34,240
notified so again the applicant or mah
1168
00:45:30,240 --> 00:45:36,560
will be notified and this cancellation
1169
00:45:34,240 --> 00:45:39,440
of course will also result in a
1170
00:45:36,560 --> 00:45:42,400
cancellation fee so an invoice will be
1171
00:45:39,440 --> 00:45:44,960
sent accordingly um applicants and mahs
1172
00:45:42,400 --> 00:45:47,200
will also be prompted in case there are
1173
00:45:44,960 --> 00:45:49,280
modifications of the inspection
1174
00:45:47,200 --> 00:45:52,319
request after the committee adoption so
1175
00:45:49,280 --> 00:45:53,839
for example sometimes the inspection
1176
00:45:52,319 --> 00:45:56,480
team changes
1177
00:45:53,839 --> 00:45:58,960
so the inspectors involved are different
1178
00:45:56,480 --> 00:46:00,400
sometimes the reporting deadline
1179
00:45:58,960 --> 00:46:02,400
is different
1180
00:46:00,400 --> 00:46:05,200
and of course because these details are
1181
00:46:02,400 --> 00:46:07,839
important we will let you know last but
1182
00:46:05,200 --> 00:46:09,200
not least we will notify you at the end
1183
00:46:07,839 --> 00:46:12,560
of the process
1184
00:46:09,200 --> 00:46:15,440
uh when the inspection report has been
1185
00:46:12,560 --> 00:46:17,520
finalized and validated and you will be
1186
00:46:15,440 --> 00:46:19,680
able to see the inspection outcome in
1187
00:46:17,520 --> 00:46:22,400
the industry portal
1188
00:46:19,680 --> 00:46:25,359
so just to give you a flavor a mock
1189
00:46:22,400 --> 00:46:26,839
example of how an application would look
1190
00:46:25,359 --> 00:46:29,760
like
1191
00:46:26,839 --> 00:46:33,520
um this is just
1192
00:46:29,760 --> 00:46:34,720
a genetic text so when we adopt an
1193
00:46:33,520 --> 00:46:37,920
inspection
1194
00:46:34,720 --> 00:46:40,240
um by the committee you will receive a
1195
00:46:37,920 --> 00:46:42,960
message very short that says
1196
00:46:40,240 --> 00:46:44,560
dear applicant contact point of the mah
1197
00:46:42,960 --> 00:46:47,200
we would like to inform you that an
1198
00:46:44,560 --> 00:46:50,240
inspection with reference number
1199
00:46:47,200 --> 00:46:52,160
xyz has been adopted by the relevant
1200
00:46:50,240 --> 00:46:54,640
committee and the details can be
1201
00:46:52,160 --> 00:46:56,079
accessed via the iris industry portal
1202
00:46:54,640 --> 00:46:57,520
please let us know if you have any
1203
00:46:56,079 --> 00:47:00,160
questions or comments
1204
00:46:57,520 --> 00:47:03,119
so if when you receive this notification
1205
00:47:00,160 --> 00:47:05,920
you already have access to iris you see
1206
00:47:03,119 --> 00:47:08,000
that you have a comment or a question
1207
00:47:05,920 --> 00:47:10,319
about that particular inspection
1208
00:47:08,000 --> 00:47:12,079
the way you would communicate with ema
1209
00:47:10,319 --> 00:47:14,720
is via
1210
00:47:12,079 --> 00:47:15,760
the messaging system that exists within
1211
00:47:14,720 --> 00:47:18,319
iris
1212
00:47:15,760 --> 00:47:21,040
it's like an outlook functionality and
1213
00:47:18,319 --> 00:47:23,760
you can type your messages send your
1214
00:47:21,040 --> 00:47:26,000
questions and it will be received by
1215
00:47:23,760 --> 00:47:28,880
whoever is the inspection coordinator at
1216
00:47:26,000 --> 00:47:32,240
ema another very important point that i
1217
00:47:28,880 --> 00:47:34,400
cannot stress enough is that because we
1218
00:47:32,240 --> 00:47:38,000
are not going to send announcement
1219
00:47:34,400 --> 00:47:40,319
letters via user link anymore the date
1220
00:47:38,000 --> 00:47:43,119
of the notification that you have on the
1221
00:47:40,319 --> 00:47:44,960
screen so when we notify you that an
1222
00:47:43,119 --> 00:47:47,200
inspection has been adopted by the
1223
00:47:44,960 --> 00:47:49,119
relevant committee
1224
00:47:47,200 --> 00:47:52,800
that will serve as the official
1225
00:47:49,119 --> 00:47:54,079
notification date so don't expect a pdf
1226
00:47:52,800 --> 00:47:57,040
document
1227
00:47:54,079 --> 00:48:00,559
that date when the notification is sent
1228
00:47:57,040 --> 00:48:02,400
will be the cutoff point
1229
00:48:00,559 --> 00:48:04,960
meaning that if an inspection is
1230
00:48:02,400 --> 00:48:07,839
cancelled after that date
1231
00:48:04,960 --> 00:48:10,240
then a cancellation fee will apply
1232
00:48:07,839 --> 00:48:12,880
and i want you to remember this it's
1233
00:48:10,240 --> 00:48:15,520
also included in the guidance
1234
00:48:12,880 --> 00:48:17,680
that we will be publishing of course we
1235
00:48:15,520 --> 00:48:19,760
have developed some guidance not only
1236
00:48:17,680 --> 00:48:21,920
for inspectors but also for industry
1237
00:48:19,760 --> 00:48:23,040
users who are involved in ema
1238
00:48:21,920 --> 00:48:26,079
inspections
1239
00:48:23,040 --> 00:48:29,200
and we will make sure that this is
1240
00:48:26,079 --> 00:48:30,880
highlighted there because when you when
1241
00:48:29,200 --> 00:48:32,880
you log in through the portal and you
1242
00:48:30,880 --> 00:48:36,079
provide the relevant documentation or pu
1243
00:48:32,880 --> 00:48:38,640
number you will be required to
1244
00:48:36,079 --> 00:48:40,240
tick the box that
1245
00:48:38,640 --> 00:48:42,160
confirms that you have read and
1246
00:48:40,240 --> 00:48:43,920
understood that information that
1247
00:48:42,160 --> 00:48:46,160
guidance and
1248
00:48:43,920 --> 00:48:47,440
um we are now
1249
00:48:46,160 --> 00:48:50,960
moving towards the end of the
1250
00:48:47,440 --> 00:48:52,640
presentation before we do the video and
1251
00:48:50,960 --> 00:48:55,599
we show you the actual
1252
00:48:52,640 --> 00:48:59,680
iris industry portal live i just want to
1253
00:48:55,599 --> 00:49:01,599
talk to you about the next steps um
1254
00:48:59,680 --> 00:49:04,240
we are following as i mentioned earlier
1255
00:49:01,599 --> 00:49:06,400
a faced approach for the go live
1256
00:49:04,240 --> 00:49:08,720
so gmp inspections are going to go live
1257
00:49:06,400 --> 00:49:11,839
in september as i said originally
1258
00:49:08,720 --> 00:49:13,760
planned for next monday the 13th but now
1259
00:49:11,839 --> 00:49:16,079
we have received the confirmation that
1260
00:49:13,760 --> 00:49:18,960
this will happen a few days later for
1261
00:49:16,079 --> 00:49:21,520
gcp it will happen between the end of
1262
00:49:18,960 --> 00:49:23,200
september and beginning of october and
1263
00:49:21,520 --> 00:49:25,680
for pharmacovigilance inspections we
1264
00:49:23,200 --> 00:49:27,920
will let you know once this is confirmed
1265
00:49:25,680 --> 00:49:30,079
as i mentioned also we we've been
1266
00:49:27,920 --> 00:49:34,160
running training sessions on the use of
1267
00:49:30,079 --> 00:49:36,640
ids particularly focusing on inspections
1268
00:49:34,160 --> 00:49:39,760
we've been training our colleagues who
1269
00:49:36,640 --> 00:49:42,480
will be managing inspections at ema we
1270
00:49:39,760 --> 00:49:44,240
have had a session with inspectors we
1271
00:49:42,480 --> 00:49:46,480
are going to have as i said a training
1272
00:49:44,240 --> 00:49:48,800
for committee members next week and we
1273
00:49:46,480 --> 00:49:51,280
are also doing this session on gmp and
1274
00:49:48,800 --> 00:49:53,119
gcp for industry and also the one we
1275
00:49:51,280 --> 00:49:54,319
will have later on in the year for
1276
00:49:53,119 --> 00:49:56,880
pharmacov
1277
00:49:54,319 --> 00:49:58,400
and one important point i think um you
1278
00:49:56,880 --> 00:50:01,119
were asking in the chat
1279
00:49:58,400 --> 00:50:03,760
this presentation is being recorded this
1280
00:50:01,119 --> 00:50:06,559
training session is recorded and we will
1281
00:50:03,760 --> 00:50:08,160
make the recording available to you
1282
00:50:06,559 --> 00:50:11,119
and you can of course provide this
1283
00:50:08,160 --> 00:50:13,359
recording to your colleagues in the in
1284
00:50:11,119 --> 00:50:16,000
your companies who perhaps were not able
1285
00:50:13,359 --> 00:50:18,480
to join us today and last but not least
1286
00:50:16,000 --> 00:50:20,720
i just want to reassure you that of
1287
00:50:18,480 --> 00:50:22,800
course this is a new process and it
1288
00:50:20,720 --> 00:50:24,880
means that we all need to go through
1289
00:50:22,800 --> 00:50:25,599
this learning curve and
1290
00:50:24,880 --> 00:50:27,839
to
1291
00:50:25,599 --> 00:50:29,839
ease the path and and support you we
1292
00:50:27,839 --> 00:50:32,319
have a couple of channels through which
1293
00:50:29,839 --> 00:50:34,720
you can reach out to us
1294
00:50:32,319 --> 00:50:36,480
one of them is via the id service desk
1295
00:50:34,720 --> 00:50:38,720
in case you have technical issues and
1296
00:50:36,480 --> 00:50:40,960
this could be for example that you need
1297
00:50:38,720 --> 00:50:41,760
to reset your password
1298
00:50:40,960 --> 00:50:44,559
or
1299
00:50:41,760 --> 00:50:46,960
um you are struggling to access ids and
1300
00:50:44,559 --> 00:50:49,040
maybe there is a problem with your um
1301
00:50:46,960 --> 00:50:51,760
user account so those things you can
1302
00:50:49,040 --> 00:50:53,839
report via the id service desk if you
1303
00:50:51,760 --> 00:50:55,920
have a more business related question
1304
00:50:53,839 --> 00:50:57,680
i'm not sure what the process is about
1305
00:50:55,920 --> 00:50:59,200
i'm not sure why i have been charged
1306
00:50:57,680 --> 00:51:01,599
this particular fee
1307
00:50:59,200 --> 00:51:03,160
then you can reach out to us via the
1308
00:51:01,599 --> 00:51:06,160
iris at
1309
00:51:03,160 --> 00:51:08,400
ema.europa.eu mailbox as i said i'm
1310
00:51:06,160 --> 00:51:10,720
gonna take you now through a video
1311
00:51:08,400 --> 00:51:12,480
and i will post the video to walk you
1312
00:51:10,720 --> 00:51:15,599
through the steps that you will need to
1313
00:51:12,480 --> 00:51:16,960
follow when you have access
1314
00:51:15,599 --> 00:51:18,559
to the iris
1315
00:51:16,960 --> 00:51:20,079
industry portal
1316
00:51:18,559 --> 00:51:22,000
so
1317
00:51:20,079 --> 00:51:23,839
this is what you can see right now on
1318
00:51:22,000 --> 00:51:27,359
the screen is the
1319
00:51:23,839 --> 00:51:29,599
landing page of iris and this is the
1320
00:51:27,359 --> 00:51:31,200
this is the page you will reach if you
1321
00:51:29,599 --> 00:51:33,920
follow the link that i included in the
1322
00:51:31,200 --> 00:51:35,440
presentation that as i said we will
1323
00:51:33,920 --> 00:51:37,599
share with you
1324
00:51:35,440 --> 00:51:40,800
just note that what i'm presenting right
1325
00:51:37,599 --> 00:51:43,359
now is uat environment so there may be
1326
00:51:40,800 --> 00:51:45,440
some things that are not quite
1327
00:51:43,359 --> 00:51:47,920
the way you will see them in production
1328
00:51:45,440 --> 00:51:51,280
but we are using these um
1329
00:51:47,920 --> 00:51:53,839
for illustrative purposes so once you
1330
00:51:51,280 --> 00:51:56,400
get to this landing page you see here
1331
00:51:53,839 --> 00:51:59,760
with this red square you have rectangle
1332
00:51:56,400 --> 00:52:01,520
i should say you have the sign-in button
1333
00:51:59,760 --> 00:52:03,200
and this will allow you to enter your
1334
00:52:01,520 --> 00:52:05,040
credentials
1335
00:52:03,200 --> 00:52:07,440
so once you
1336
00:52:05,040 --> 00:52:11,359
enter your credentials what you can do
1337
00:52:07,440 --> 00:52:13,440
is you can go at the top of the screen
1338
00:52:11,359 --> 00:52:16,800
you have a section that is called
1339
00:52:13,440 --> 00:52:18,319
submissions and you can view your draft
1340
00:52:16,800 --> 00:52:19,280
submissions
1341
00:52:18,319 --> 00:52:22,000
so
1342
00:52:19,280 --> 00:52:24,400
as i said we as ema we will create the
1343
00:52:22,000 --> 00:52:26,800
case and the case will lead to the
1344
00:52:24,400 --> 00:52:29,119
generation of a submission for each mah
1345
00:52:26,800 --> 00:52:31,119
so for each product i should say for
1346
00:52:29,119 --> 00:52:32,079
each product that is included in the
1347
00:52:31,119 --> 00:52:33,920
scope of
1348
00:52:32,079 --> 00:52:38,240
an inspection
1349
00:52:33,920 --> 00:52:38,240
and then what will happen is that
1350
00:52:40,400 --> 00:52:43,040
let me just
1351
00:52:43,119 --> 00:52:47,280
here
1352
00:52:44,720 --> 00:52:49,280
so you go to my draft submissions
1353
00:52:47,280 --> 00:52:52,079
and then you can see under draft
1354
00:52:49,280 --> 00:52:52,079
submissions
1355
00:52:55,440 --> 00:53:00,400
under draft submissions you have a table
1356
00:52:58,000 --> 00:53:02,880
the way the table is structured is you
1357
00:53:00,400 --> 00:53:04,800
have the first column that is a parent
1358
00:53:02,880 --> 00:53:05,760
submission id it's just the reference
1359
00:53:04,800 --> 00:53:07,680
number
1360
00:53:05,760 --> 00:53:09,280
that the um
1361
00:53:07,680 --> 00:53:11,119
that the system generates and it's
1362
00:53:09,280 --> 00:53:14,480
exactly the same as the submission id
1363
00:53:11,119 --> 00:53:16,319
there are no differences um so you don't
1364
00:53:14,480 --> 00:53:19,839
need to worry about but it's important
1365
00:53:16,319 --> 00:53:22,960
that you quote this number if necessary
1366
00:53:19,839 --> 00:53:24,720
um when you're communicating with us um
1367
00:53:22,960 --> 00:53:26,559
this is a number that will be present
1368
00:53:24,720 --> 00:53:29,359
throughout the system and it just
1369
00:53:26,559 --> 00:53:31,359
identifies that particular inspection
1370
00:53:29,359 --> 00:53:33,359
then you will see
1371
00:53:31,359 --> 00:53:35,599
the submission type meaning okay what
1372
00:53:33,359 --> 00:53:37,839
type of inspection is this is it the gmp
1373
00:53:35,599 --> 00:53:39,280
inspection the gcp pharmacoviral
1374
00:53:37,839 --> 00:53:41,200
inspection
1375
00:53:39,280 --> 00:53:43,839
then you see the next column is called
1376
00:53:41,200 --> 00:53:43,839
sponsor
1377
00:53:44,319 --> 00:53:47,599
actually
1378
00:53:45,359 --> 00:53:50,640
these this would most likely be replaced
1379
00:53:47,599 --> 00:53:53,440
to mah applicant sponsor because we have
1380
00:53:50,640 --> 00:53:55,280
this this convention for various
1381
00:53:53,440 --> 00:53:56,400
procedures at ema
1382
00:53:55,280 --> 00:53:58,880
then you have
1383
00:53:56,400 --> 00:54:02,800
subject and modified on
1384
00:53:58,880 --> 00:54:05,280
so when you are on this screen you have
1385
00:54:02,800 --> 00:54:08,000
on the right hand side you have an arrow
1386
00:54:05,280 --> 00:54:11,440
that allows you to view or manage
1387
00:54:08,000 --> 00:54:14,240
contributors also view manage managers
1388
00:54:11,440 --> 00:54:16,000
and also manage submission contacts so
1389
00:54:14,240 --> 00:54:18,240
let's start with the view manage
1390
00:54:16,000 --> 00:54:21,960
contributors
1391
00:54:18,240 --> 00:54:21,960
so as you can see
1392
00:54:27,359 --> 00:54:31,200
as you can see once you click on view
1393
00:54:29,280 --> 00:54:34,079
and manage contributors
1394
00:54:31,200 --> 00:54:37,200
you get to this screen where you have a
1395
00:54:34,079 --> 00:54:38,400
button that allows you to add so this is
1396
00:54:37,200 --> 00:54:40,880
the role that
1397
00:54:38,400 --> 00:54:43,200
carlo was referring earlier who is a
1398
00:54:40,880 --> 00:54:45,839
person who can view
1399
00:54:43,200 --> 00:54:48,720
a particular submission
1400
00:54:45,839 --> 00:54:49,920
and you can add this name by clicking on
1401
00:54:48,720 --> 00:54:53,119
this blue
1402
00:54:49,920 --> 00:54:55,520
button here and once you add that person
1403
00:54:53,119 --> 00:54:57,200
the person contact details will appear
1404
00:54:55,520 --> 00:54:59,680
in the subsequent
1405
00:54:57,200 --> 00:54:59,680
table
1406
00:55:01,440 --> 00:55:06,000
if we go back to the previous screen the
1407
00:55:03,920 --> 00:55:08,079
next option that you have under view and
1408
00:55:06,000 --> 00:55:10,319
manage contributors is called view and
1409
00:55:08,079 --> 00:55:12,799
manage managers and
1410
00:55:10,319 --> 00:55:14,799
you have this highlighted with a red
1411
00:55:12,799 --> 00:55:17,359
rectangle at the moment
1412
00:55:14,799 --> 00:55:20,079
the way you view and manage managers and
1413
00:55:17,359 --> 00:55:22,160
the way you manage submission contacts
1414
00:55:20,079 --> 00:55:24,319
it's exactly the same so in the next
1415
00:55:22,160 --> 00:55:26,240
screen i'm going to show you
1416
00:55:24,319 --> 00:55:28,160
how you view and manage managers but
1417
00:55:26,240 --> 00:55:31,720
this is is applicable also to the
1418
00:55:28,160 --> 00:55:31,720
submission contacts
1419
00:55:34,720 --> 00:55:38,640
so you can see this screen looks like
1420
00:55:37,200 --> 00:55:40,400
the one i showed you before for the
1421
00:55:38,640 --> 00:55:42,319
contributors
1422
00:55:40,400 --> 00:55:43,760
you click on add
1423
00:55:42,319 --> 00:55:46,559
and you can
1424
00:55:43,760 --> 00:55:48,160
select the name of the person it appears
1425
00:55:46,559 --> 00:55:50,319
together with this email address
1426
00:55:48,160 --> 00:55:53,200
underneath and then
1427
00:55:50,319 --> 00:55:55,760
you click on done and that that manager
1428
00:55:53,200 --> 00:55:55,760
is added
1429
00:55:58,960 --> 00:56:02,960
as i said the draft
1430
00:56:01,200 --> 00:56:05,040
sorry the manage submission contact the
1431
00:56:02,960 --> 00:56:07,599
submission contacts are added in the
1432
00:56:05,040 --> 00:56:10,000
same way and then you just save and
1433
00:56:07,599 --> 00:56:10,000
return
1434
00:56:13,839 --> 00:56:17,119
so
1435
00:56:14,559 --> 00:56:19,599
the next option that you have actually
1436
00:56:17,119 --> 00:56:23,040
that appears at the top of this drop
1437
00:56:19,599 --> 00:56:25,200
down menu it's edit draft
1438
00:56:23,040 --> 00:56:26,960
it might uh
1439
00:56:25,200 --> 00:56:29,200
it might be that you're wondering okay
1440
00:56:26,960 --> 00:56:31,359
what is exactly what we can edit because
1441
00:56:29,200 --> 00:56:33,760
of course you cannot edit the type of
1442
00:56:31,359 --> 00:56:35,440
inspection you cannot edit the products
1443
00:56:33,760 --> 00:56:37,280
that are in scope of inspection you
1444
00:56:35,440 --> 00:56:39,359
cannot edit in the case of gmp
1445
00:56:37,280 --> 00:56:42,480
inspections the manufacturing activities
1446
00:56:39,359 --> 00:56:44,880
because this is all determined by ema in
1447
00:56:42,480 --> 00:56:46,880
collaboration with the ncas
1448
00:56:44,880 --> 00:56:49,119
but what you can do when you click on
1449
00:56:46,880 --> 00:56:52,720
edit draft
1450
00:56:49,119 --> 00:56:52,720
is you can add
1451
00:56:52,960 --> 00:56:58,160
you can
1452
00:56:54,079 --> 00:56:59,760
have a look at the inspection overview
1453
00:56:58,160 --> 00:57:02,319
you can view the details of the
1454
00:56:59,760 --> 00:57:02,319
inspection
1455
00:57:02,720 --> 00:57:07,920
so here on this screen under the
1456
00:57:05,280 --> 00:57:09,440
inspection overview
1457
00:57:07,920 --> 00:57:11,040
what you can see is the type of
1458
00:57:09,440 --> 00:57:13,040
inspection in this case it's the post
1459
00:57:11,040 --> 00:57:14,880
authorization inspection
1460
00:57:13,040 --> 00:57:16,960
uh it gives you what's the name of the
1461
00:57:14,880 --> 00:57:18,799
lead inspectorate it gives you the name
1462
00:57:16,960 --> 00:57:21,280
of the supporting inspectorate together
1463
00:57:18,799 --> 00:57:23,200
with the addresses of the ncas it will
1464
00:57:21,280 --> 00:57:25,760
give you the reporting deadline so even
1465
00:57:23,200 --> 00:57:29,920
if here you see it's blank you will be
1466
00:57:25,760 --> 00:57:29,920
able to see it in in production
1467
00:57:30,319 --> 00:57:35,359
and then if you scroll down
1468
00:57:32,799 --> 00:57:38,079
you will see the inspection contacts so
1469
00:57:35,359 --> 00:57:39,920
the difference between the
1470
00:57:38,079 --> 00:57:42,319
contacts that you have at the top and
1471
00:57:39,920 --> 00:57:43,839
the contacts that you have underneath is
1472
00:57:42,319 --> 00:57:47,119
that at the top you have the
1473
00:57:43,839 --> 00:57:49,280
inspectorate contact so at ema for gmp
1474
00:57:47,119 --> 00:57:51,440
inspections we normally liaise with one
1475
00:57:49,280 --> 00:57:53,359
contact point per nca
1476
00:57:51,440 --> 00:57:55,920
but then underneath what you see is the
1477
00:57:53,359 --> 00:57:58,160
names of the actual inspectors who will
1478
00:57:55,920 --> 00:58:00,240
be involved in the inspection
1479
00:57:58,160 --> 00:58:02,720
you can see whether their role is a lead
1480
00:58:00,240 --> 00:58:04,960
inspector or just inspector meaning
1481
00:58:02,720 --> 00:58:07,440
supporting and then you can also see
1482
00:58:04,960 --> 00:58:10,160
their email addresses and the ncaa they
1483
00:58:07,440 --> 00:58:10,160
belong to
1484
00:58:14,799 --> 00:58:20,079
when you click on the button return the
1485
00:58:17,280 --> 00:58:22,240
screen will go back to the submission
1486
00:58:20,079 --> 00:58:25,359
form screen and then you can click on
1487
00:58:22,240 --> 00:58:25,359
inspection details
1488
00:58:26,079 --> 00:58:32,160
and under inspection details what you
1489
00:58:28,160 --> 00:58:34,400
can see is the actual products so
1490
00:58:32,160 --> 00:58:36,400
here as i said you will only be able to
1491
00:58:34,400 --> 00:58:38,319
see the products
1492
00:58:36,400 --> 00:58:40,480
in scope of the inspection for which you
1493
00:58:38,319 --> 00:58:42,319
hold the marketing authorization and you
1494
00:58:40,480 --> 00:58:45,359
will see not only the product name but
1495
00:58:42,319 --> 00:58:48,000
also the product number that ema whether
1496
00:58:45,359 --> 00:58:50,400
it's human or vet that's the domain
1497
00:58:48,000 --> 00:58:52,559
the active substance
1498
00:58:50,400 --> 00:58:54,079
the number of fees that apply
1499
00:58:52,559 --> 00:58:56,160
and also
1500
00:58:54,079 --> 00:58:58,720
you are able to see the pharmaceutical
1501
00:58:56,160 --> 00:59:01,200
form and strength of course and most
1502
00:58:58,720 --> 00:59:02,559
importantly the manufacturing operations
1503
00:59:01,200 --> 00:59:04,160
so
1504
00:59:02,559 --> 00:59:06,640
the products together with the
1505
00:59:04,160 --> 00:59:10,319
manufacturing operations will
1506
00:59:06,640 --> 00:59:12,240
determine the scope of the inspection
1507
00:59:10,319 --> 00:59:14,559
now one more thing that you can do while
1508
00:59:12,240 --> 00:59:16,960
you are on this screen is you can see
1509
00:59:14,559 --> 00:59:19,599
here on the right hand side you have a
1510
00:59:16,960 --> 00:59:20,640
column that refers to the purchase order
1511
00:59:19,599 --> 00:59:23,040
number
1512
00:59:20,640 --> 00:59:24,480
and you have a little arrow that when
1513
00:59:23,040 --> 00:59:27,680
you click on it
1514
00:59:24,480 --> 00:59:30,319
you have the possibility to edit and
1515
00:59:27,680 --> 00:59:32,319
here is the field where you will enter
1516
00:59:30,319 --> 00:59:34,640
your purchase order number for this
1517
00:59:32,319 --> 00:59:37,200
particular product
1518
00:59:34,640 --> 00:59:40,319
you also have the possibility to enter
1519
00:59:37,200 --> 00:59:42,400
some comments but i would um
1520
00:59:40,319 --> 00:59:45,440
suggest i would encourage you that if
1521
00:59:42,400 --> 00:59:47,760
you have questions or really critical
1522
00:59:45,440 --> 00:59:50,240
issues that you want to discuss with ema
1523
00:59:47,760 --> 00:59:51,680
that instead of using this box that you
1524
00:59:50,240 --> 00:59:53,920
have underneath
1525
00:59:51,680 --> 00:59:57,599
that allows you to enter free text field
1526
00:59:53,920 --> 01:00:00,160
if you really need a response from ema
1527
00:59:57,599 --> 01:00:01,680
that you use the messaging functionality
1528
01:00:00,160 --> 01:00:04,640
in iris
1529
01:00:01,680 --> 01:00:06,000
to communicate
1530
01:00:04,640 --> 01:00:08,640
to communicate with the relevant
1531
01:00:06,000 --> 01:00:10,319
inspection coordinator meaning that you
1532
01:00:08,640 --> 01:00:12,160
when you receive a notification from
1533
01:00:10,319 --> 01:00:14,799
iris you can respond to that
1534
01:00:12,160 --> 01:00:18,240
notification and very important
1535
01:00:14,799 --> 01:00:18,240
don't change the subject
1536
01:00:21,040 --> 01:00:26,400
so as you can see
1537
01:00:23,440 --> 01:00:28,400
when you click on edit there is a
1538
01:00:26,400 --> 01:00:30,160
field that gets displayed
1539
01:00:28,400 --> 01:00:31,839
purchase order number this is what you
1540
01:00:30,160 --> 01:00:35,200
would enter it
1541
01:00:31,839 --> 01:00:35,200
and then you click on submit
1542
01:00:39,760 --> 01:00:45,599
if you go back to the previous screen
1543
01:00:42,640 --> 01:00:47,920
here document from applicant here is
1544
01:00:45,599 --> 01:00:50,720
where when you click on it you have the
1545
01:00:47,920 --> 01:00:52,480
possibility to upload the documents that
1546
01:00:50,720 --> 01:00:55,200
you would need for example in the
1547
01:00:52,480 --> 01:00:57,280
context of a gcp inspection
1548
01:00:55,200 --> 01:00:59,520
all the documents that are required for
1549
01:00:57,280 --> 01:01:01,920
a gcp inspection
1550
01:00:59,520 --> 01:01:04,559
are detailed in the guidance that we are
1551
01:01:01,920 --> 01:01:06,240
publishing and that you are required to
1552
01:01:04,559 --> 01:01:08,480
read and confirm that you have read and
1553
01:01:06,240 --> 01:01:10,559
understood so when you click on document
1554
01:01:08,480 --> 01:01:12,079
from applicant
1555
01:01:10,559 --> 01:01:15,359
as you can see
1556
01:01:12,079 --> 01:01:17,920
it's very easy to add any files
1557
01:01:15,359 --> 01:01:19,839
you just click on the relevant button
1558
01:01:17,920 --> 01:01:22,079
that is highlighted here
1559
01:01:19,839 --> 01:01:23,359
and then you simply
1560
01:01:22,079 --> 01:01:25,280
upload
1561
01:01:23,359 --> 01:01:27,040
all the documentation
1562
01:01:25,280 --> 01:01:29,599
the system will ask you to choose the
1563
01:01:27,040 --> 01:01:31,760
files you select them as you would do
1564
01:01:29,599 --> 01:01:34,640
with any other system and you just click
1565
01:01:31,760 --> 01:01:34,640
on add files
1566
01:01:34,720 --> 01:01:39,119
once that is done
1567
01:01:37,119 --> 01:01:41,680
if i go back to this screen
1568
01:01:39,119 --> 01:01:44,240
you will see that there is a
1569
01:01:41,680 --> 01:01:46,400
section that says document from ema and
1570
01:01:44,240 --> 01:01:48,880
declare and submit the changes
1571
01:01:46,400 --> 01:01:51,200
in documents from ema if you click on
1572
01:01:48,880 --> 01:01:53,599
that you will find
1573
01:01:51,200 --> 01:01:56,079
any documents that ema would like to
1574
01:01:53,599 --> 01:01:57,839
share with you as the mah and we will
1575
01:01:56,079 --> 01:02:00,400
upload them in sharepoint and there will
1576
01:01:57,839 --> 01:02:02,160
be available to you for viewing through
1577
01:02:00,400 --> 01:02:05,039
that link
1578
01:02:02,160 --> 01:02:07,599
the last step would be to declare and
1579
01:02:05,039 --> 01:02:09,920
submit the changes meaning the
1580
01:02:07,599 --> 01:02:12,400
documentation that you have uploaded and
1581
01:02:09,920 --> 01:02:14,160
the po number that you have entered and
1582
01:02:12,400 --> 01:02:16,400
then when you click on this last
1583
01:02:14,160 --> 01:02:17,839
hyperlink the following screen will
1584
01:02:16,400 --> 01:02:19,200
appear
1585
01:02:17,839 --> 01:02:20,640
so
1586
01:02:19,200 --> 01:02:23,280
very important
1587
01:02:20,640 --> 01:02:26,160
that you read this declaration
1588
01:02:23,280 --> 01:02:27,680
because once you have clicked on submit
1589
01:02:26,160 --> 01:02:30,400
application
1590
01:02:27,680 --> 01:02:32,240
then the form will be locked
1591
01:02:30,400 --> 01:02:34,880
meaning that you will not be able to
1592
01:02:32,240 --> 01:02:37,680
change it you are also required as i
1593
01:02:34,880 --> 01:02:39,200
said to click on this tick box
1594
01:02:37,680 --> 01:02:41,359
to confirm that you have read and
1595
01:02:39,200 --> 01:02:43,920
understood the guidance for applicants
1596
01:02:41,359 --> 01:02:45,839
and mi ages involved in ema inspections
1597
01:02:43,920 --> 01:02:47,440
and that you as the person authorized to
1598
01:02:45,839 --> 01:02:50,480
sign
1599
01:02:47,440 --> 01:02:52,319
that the content is okay to be submitted
1600
01:02:50,480 --> 01:02:54,799
you can see that the guidance is in blue
1601
01:02:52,319 --> 01:02:55,920
because this is a hyperlink so before
1602
01:02:54,799 --> 01:02:58,400
you
1603
01:02:55,920 --> 01:03:00,160
actually click you have very easily
1604
01:02:58,400 --> 01:03:01,839
access to the guidance
1605
01:03:00,160 --> 01:03:04,480
once you have read it just click on
1606
01:03:01,839 --> 01:03:06,559
submit application and then the the
1607
01:03:04,480 --> 01:03:09,440
submission will be locked
1608
01:03:06,559 --> 01:03:11,119
the system will ask you one more time
1609
01:03:09,440 --> 01:03:14,160
in case you realize that actually you've
1610
01:03:11,119 --> 01:03:16,960
forgotten something so um
1611
01:03:14,160 --> 01:03:18,960
you have a double check here um
1612
01:03:16,960 --> 01:03:20,640
you can at this point review the
1613
01:03:18,960 --> 01:03:23,280
application if you click on the relevant
1614
01:03:20,640 --> 01:03:26,960
button or you can say no i'm sure this
1615
01:03:23,280 --> 01:03:28,960
is fine um i'm i'm comfortable with my
1616
01:03:26,960 --> 01:03:30,480
details my data and i just want to
1617
01:03:28,960 --> 01:03:33,520
submit
1618
01:03:30,480 --> 01:03:36,400
and once you click on the submit button
1619
01:03:33,520 --> 01:03:38,559
you will receive this
1620
01:03:36,400 --> 01:03:40,559
this message indicating that the
1621
01:03:38,559 --> 01:03:42,319
application has been submitted
1622
01:03:40,559 --> 01:03:45,200
successfully
1623
01:03:42,319 --> 01:03:46,559
and with this uh we have concluded the
1624
01:03:45,200 --> 01:03:49,520
work through the
1625
01:03:46,559 --> 01:03:52,319
the video of the industry portal we used
1626
01:03:49,520 --> 01:03:54,480
an example of a gmp inspection
1627
01:03:52,319 --> 01:03:56,880
but actually um
1628
01:03:54,480 --> 01:03:59,839
it's it's the same process for gcp
1629
01:03:56,880 --> 01:04:01,760
inspections the difference is one that
1630
01:03:59,839 --> 01:04:04,319
miguel highlighted earlier the fact that
1631
01:04:01,760 --> 01:04:06,400
for gcp inspections you will be required
1632
01:04:04,319 --> 01:04:08,880
to upload a number of documents but i
1633
01:04:06,400 --> 01:04:11,680
showed you how to do that and there
1634
01:04:08,880 --> 01:04:13,760
might be other fields um especially when
1635
01:04:11,680 --> 01:04:16,000
you check the inspection details that of
1636
01:04:13,760 --> 01:04:18,400
course will have a different type of
1637
01:04:16,000 --> 01:04:20,640
information if it's a gcp inspection but
1638
01:04:18,400 --> 01:04:22,559
the mechanics is the same and you will
1639
01:04:20,640 --> 01:04:26,640
follow the same process
1640
01:04:22,559 --> 01:04:31,039
so what i would suggest now because it's
1641
01:04:26,640 --> 01:04:33,839
already 11 22 is that we spent the last
1642
01:04:31,039 --> 01:04:35,359
minutes of this training session today
1643
01:04:33,839 --> 01:04:37,920
going through the questions we have
1644
01:04:35,359 --> 01:04:39,599
received in the chat we saw that there
1645
01:04:37,920 --> 01:04:42,000
are some questions related to access
1646
01:04:39,599 --> 01:04:42,799
management but because carlo is not with
1647
01:04:42,000 --> 01:04:44,799
us
1648
01:04:42,799 --> 01:04:47,280
right now what i would propose is that
1649
01:04:44,799 --> 01:04:50,079
anything related to access management we
1650
01:04:47,280 --> 01:04:52,480
review the questions of line after this
1651
01:04:50,079 --> 01:04:54,240
training we liaise with him and we come
1652
01:04:52,480 --> 01:04:55,440
back to you to provide you the answers
1653
01:04:54,240 --> 01:04:57,599
in writing
1654
01:04:55,440 --> 01:05:00,559
and in these few minutes that we have
1655
01:04:57,599 --> 01:05:02,960
left we focus on the actual questions
1656
01:05:00,559 --> 01:05:05,680
related to the business process and we
1657
01:05:02,960 --> 01:05:06,960
answer as many as we can so dunya over
1658
01:05:05,680 --> 01:05:09,760
to you
1659
01:05:06,960 --> 01:05:12,079
thank you ester so the first question is
1660
01:05:09,760 --> 01:05:14,720
can alerts be set in order not to check
1661
01:05:12,079 --> 01:05:17,119
the platform every day
1662
01:05:14,720 --> 01:05:19,760
so the notifications will be set up from
1663
01:05:17,119 --> 01:05:22,480
our site to prompt you when an
1664
01:05:19,760 --> 01:05:24,240
inspection has been adopted for example
1665
01:05:22,480 --> 01:05:25,599
so you don't need to check the platform
1666
01:05:24,240 --> 01:05:26,880
every day you will receive the
1667
01:05:25,599 --> 01:05:29,200
notification
1668
01:05:26,880 --> 01:05:31,200
when an inspection is adopted and you
1669
01:05:29,200 --> 01:05:32,640
will also receive notifications as i
1670
01:05:31,200 --> 01:05:34,960
mentioned earlier
1671
01:05:32,640 --> 01:05:36,880
when an inspection is canceled when an
1672
01:05:34,960 --> 01:05:38,960
inspection is modified
1673
01:05:36,880 --> 01:05:40,960
or at the end of the process with the
1674
01:05:38,960 --> 01:05:43,200
when the inspection is concluded so
1675
01:05:40,960 --> 01:05:45,599
there are milestones at which you will
1676
01:05:43,200 --> 01:05:50,079
receive notifications
1677
01:05:45,599 --> 01:05:51,680
and this will be set up by email
1678
01:05:50,079 --> 01:05:53,440
uh for the next question i will give
1679
01:05:51,680 --> 01:05:57,280
floor to miguel
1680
01:05:53,440 --> 01:05:59,119
will there be a link with ctis and iris
1681
01:05:57,280 --> 01:06:02,079
okay thank you for the question at the
1682
01:05:59,119 --> 01:06:03,760
moment is it was outside of the scope of
1683
01:06:02,079 --> 01:06:06,720
of this project
1684
01:06:03,760 --> 01:06:10,400
but anyway we used an agile system in
1685
01:06:06,720 --> 01:06:12,079
order to to create iris for inspection
1686
01:06:10,400 --> 01:06:14,720
so we may be considered at the future
1687
01:06:12,079 --> 01:06:16,799
with the if we think is relevant and
1688
01:06:14,720 --> 01:06:19,119
useful
1689
01:06:16,799 --> 01:06:20,160
thank you miguel a third next question
1690
01:06:19,119 --> 01:06:21,520
is for you
1691
01:06:20,160 --> 01:06:24,000
does a company that is only a
1692
01:06:21,520 --> 01:06:25,280
manufacturer not an mh need an iris
1693
01:06:24,000 --> 01:06:28,079
account
1694
01:06:25,280 --> 01:06:31,200
a very good question the answer is no
1695
01:06:28,079 --> 01:06:33,280
because ema only communicates for gmp
1696
01:06:31,200 --> 01:06:36,319
and gcp inspections only communicates
1697
01:06:33,280 --> 01:06:38,240
with the mih and the applicants so if
1698
01:06:36,319 --> 01:06:40,720
you belong to a company that is just a
1699
01:06:38,240 --> 01:06:43,200
manufacturer and therefore
1700
01:06:40,720 --> 01:06:46,480
a potential inspector you don't need to
1701
01:06:43,200 --> 01:06:48,799
have access to iris because the details
1702
01:06:46,480 --> 01:06:50,319
of the inspection will be communicated
1703
01:06:48,799 --> 01:06:52,799
to the mah
1704
01:06:50,319 --> 01:06:56,400
and it will be the responsibility of the
1705
01:06:52,799 --> 01:06:58,400
mah to liaise with you as an inspector
1706
01:06:56,400 --> 01:07:00,480
and also the inspectors will contact you
1707
01:06:58,400 --> 01:07:02,720
directly as an inspectee but they will
1708
01:07:00,480 --> 01:07:05,760
do so outs the next question will there
1709
01:07:02,720 --> 01:07:08,079
be a transition period after the go live
1710
01:07:05,760 --> 01:07:10,240
ie gmp gcp inspections are handled in
1711
01:07:08,079 --> 01:07:11,599
parallel by iris and the established
1712
01:07:10,240 --> 01:07:14,000
process
1713
01:07:11,599 --> 01:07:15,760
very good question as well indeed we are
1714
01:07:14,000 --> 01:07:18,240
going to have a transition period that
1715
01:07:15,760 --> 01:07:19,839
we and visit will last for
1716
01:07:18,240 --> 01:07:22,079
about 12 months
1717
01:07:19,839 --> 01:07:24,799
the reason is because for gmp
1718
01:07:22,079 --> 01:07:27,039
inspections as you know often the the
1719
01:07:24,799 --> 01:07:30,799
re-inspection sorry the report in that
1720
01:07:27,039 --> 01:07:33,440
line it can be up to a year after the
1721
01:07:30,799 --> 01:07:35,839
the time when it's requested so
1722
01:07:33,440 --> 01:07:38,640
anything any inspections that have been
1723
01:07:35,839 --> 01:07:39,920
already requested in the old system and
1724
01:07:38,640 --> 01:07:42,319
that follow the
1725
01:07:39,920 --> 01:07:44,640
as is process will be finalized
1726
01:07:42,319 --> 01:07:47,440
according to the current practice
1727
01:07:44,640 --> 01:07:49,280
after go live any inspections that
1728
01:07:47,440 --> 01:07:51,520
are in iris
1729
01:07:49,280 --> 01:07:54,799
will continue in 90s and be finalized in
1730
01:07:51,520 --> 01:07:56,960
iris so absolutely we can expect up to a
1731
01:07:54,799 --> 01:07:59,039
year of transition period where the two
1732
01:07:56,960 --> 01:08:00,960
systems will run in parallel
1733
01:07:59,039 --> 01:08:03,039
one important point i want to mention
1734
01:08:00,960 --> 01:08:05,359
here is that we are not migrating any
1735
01:08:03,039 --> 01:08:07,520
data from the old system to the new one
1736
01:08:05,359 --> 01:08:09,839
so in iris you will only see the
1737
01:08:07,520 --> 01:08:13,119
inspections that are triggered from the
1738
01:08:09,839 --> 01:08:15,599
moment we go live onwards
1739
01:08:13,119 --> 01:08:18,560
thank you next question is the invoice
1740
01:08:15,599 --> 01:08:20,799
received through iris
1741
01:08:18,560 --> 01:08:22,839
the invoice you will receive it as you
1742
01:08:20,799 --> 01:08:25,759
normally do so
1743
01:08:22,839 --> 01:08:27,279
um the process that manages ids for
1744
01:08:25,759 --> 01:08:30,239
inspections
1745
01:08:27,279 --> 01:08:32,400
is connected to the sap interface the
1746
01:08:30,239 --> 01:08:35,040
finance interface and you will continue
1747
01:08:32,400 --> 01:08:36,839
to receive the invoice in the way you
1748
01:08:35,040 --> 01:08:40,159
are receiving it
1749
01:08:36,839 --> 01:08:41,920
now i will address uh ask miguel for the
1750
01:08:40,159 --> 01:08:43,600
next two questions
1751
01:08:41,920 --> 01:08:45,040
can we understand the gcp inspections
1752
01:08:43,600 --> 01:08:47,839
for veterinary applications are
1753
01:08:45,040 --> 01:08:51,359
currently out of scope
1754
01:08:47,839 --> 01:08:51,359
no they are in a scope
1755
01:08:51,600 --> 01:08:54,400
thank you
1756
01:08:52,640 --> 01:08:56,640
can you confirm that iris will not be
1757
01:08:54,400 --> 01:08:58,480
used to send documents requested for gcp
1758
01:08:56,640 --> 01:09:00,719
inspections will we still have to send
1759
01:08:58,480 --> 01:09:03,440
them by courier on flash drives
1760
01:09:00,719 --> 01:09:06,560
okay so as i said before
1761
01:09:03,440 --> 01:09:08,719
for emea documentation any recommend any
1762
01:09:06,560 --> 01:09:11,520
documentation that at the moment we ask
1763
01:09:08,719 --> 01:09:15,359
for ema it will be done through iris
1764
01:09:11,520 --> 01:09:17,520
for the part of the inspectors um
1765
01:09:15,359 --> 01:09:19,839
you need to liaise with the
1766
01:09:17,520 --> 01:09:21,279
reporting inspectorate and agree
1767
01:09:19,839 --> 01:09:24,319
this is something that we are going to
1768
01:09:21,279 --> 01:09:26,560
discuss in the gcp inspector working
1769
01:09:24,319 --> 01:09:29,120
group and try to get
1770
01:09:26,560 --> 01:09:30,640
an agreement but i have the feeling that
1771
01:09:29,120 --> 01:09:33,520
because of the
1772
01:09:30,640 --> 01:09:36,000
large quantity of documentation and and
1773
01:09:33,520 --> 01:09:37,600
the weight of those documentation
1774
01:09:36,000 --> 01:09:42,319
uh unfortunately we will need to
1775
01:09:37,600 --> 01:09:43,679
continue with uh with the current system
1776
01:09:42,319 --> 01:09:45,679
thank you
1777
01:09:43,679 --> 01:09:49,600
esther will the ema communicate with the
1778
01:09:45,679 --> 01:09:51,120
gmp site directly as well as the mah
1779
01:09:49,600 --> 01:09:54,560
this is a bit linked to the question
1780
01:09:51,120 --> 01:09:57,040
that was posted earlier so no ema in the
1781
01:09:54,560 --> 01:09:58,080
current process ema never communicates
1782
01:09:57,040 --> 01:10:00,480
with the
1783
01:09:58,080 --> 01:10:02,560
site that is going to be inspected we
1784
01:10:00,480 --> 01:10:05,360
manage all the communication through the
1785
01:10:02,560 --> 01:10:07,520
mah or the applicant and this practice
1786
01:10:05,360 --> 01:10:09,360
will not change with the launch of iris
1787
01:10:07,520 --> 01:10:11,199
so in the future
1788
01:10:09,360 --> 01:10:13,679
we will continue all our communication
1789
01:10:11,199 --> 01:10:15,520
with the mah and the applicant it's just
1790
01:10:13,679 --> 01:10:18,239
that instead of doing it via user link
1791
01:10:15,520 --> 01:10:19,440
or email we will do it via iris
1792
01:10:18,239 --> 01:10:22,159
and
1793
01:10:19,440 --> 01:10:24,719
the the ones who will be contacting
1794
01:10:22,159 --> 01:10:26,960
directly the manufacturer are the the
1795
01:10:24,719 --> 01:10:28,400
inspection team the inspectorates as
1796
01:10:26,960 --> 01:10:30,000
they currently do
1797
01:10:28,400 --> 01:10:32,719
and for the last question we will
1798
01:10:30,000 --> 01:10:34,640
address in this training i decided to
1799
01:10:32,719 --> 01:10:36,239
choose one which is on confidentiality
1800
01:10:34,640 --> 01:10:38,560
which i mean i think it's really
1801
01:10:36,239 --> 01:10:40,480
important so inspection reports are
1802
01:10:38,560 --> 01:10:42,560
related to one manufacturing site if
1803
01:10:40,480 --> 01:10:44,400
several images are impacted by a site
1804
01:10:42,560 --> 01:10:46,400
inspection is the process to handle
1805
01:10:44,400 --> 01:10:47,840
confidentiality of a finding specific to
1806
01:10:46,400 --> 01:10:49,040
a product documented to make sure that
1807
01:10:47,840 --> 01:10:51,679
the inspection report that will be
1808
01:10:49,040 --> 01:10:53,520
visible by several mahs
1809
01:10:51,679 --> 01:10:54,880
will not compromise any confidentiality
1810
01:10:53,520 --> 01:10:57,120
issues
1811
01:10:54,880 --> 01:10:58,640
absolutely dunya this is a key question
1812
01:10:57,120 --> 01:11:00,880
and i want to make sure everyone
1813
01:10:58,640 --> 01:11:04,080
understands the process
1814
01:11:00,880 --> 01:11:07,679
at the moment ema does not share
1815
01:11:04,080 --> 01:11:10,320
any inspection report with any mah for
1816
01:11:07,679 --> 01:11:12,640
gmp inspections so as the question
1817
01:11:10,320 --> 01:11:14,000
correctly said an inspection a gmp
1818
01:11:12,640 --> 01:11:16,239
inspection
1819
01:11:14,000 --> 01:11:18,719
might cover several centrally authorized
1820
01:11:16,239 --> 01:11:22,400
products that are manufactured
1821
01:11:18,719 --> 01:11:24,480
at one particular facility however
1822
01:11:22,400 --> 01:11:27,280
neither ema is currently sharing the
1823
01:11:24,480 --> 01:11:29,760
inspection report with an email nor will
1824
01:11:27,280 --> 01:11:32,400
it do it in the future so even after we
1825
01:11:29,760 --> 01:11:35,920
launch iris the inspection report that
1826
01:11:32,400 --> 01:11:37,199
is provided from the inspectors to ema
1827
01:11:35,920 --> 01:11:40,640
will remain
1828
01:11:37,199 --> 01:11:44,400
visible only to ema and to the ncas it
1829
01:11:40,640 --> 01:11:46,560
will not be shared with any mah so it is
1830
01:11:44,400 --> 01:11:48,880
up to the inspectee
1831
01:11:46,560 --> 01:11:51,280
if the inspectee
1832
01:11:48,880 --> 01:11:53,520
has an arrangement with the mihs and
1833
01:11:51,280 --> 01:11:55,040
they wish to share it with them
1834
01:11:53,520 --> 01:11:57,120
then
1835
01:11:55,040 --> 01:11:58,400
they should have the mechanisms in place
1836
01:11:57,120 --> 01:12:01,040
to protect
1837
01:11:58,400 --> 01:12:03,040
confidentiality but from the ema side
1838
01:12:01,040 --> 01:12:05,679
please rest assured that we ensure
1839
01:12:03,040 --> 01:12:08,960
confidentiality by not sharing the
1840
01:12:05,679 --> 01:12:11,760
inspection report with any mah i can see
1841
01:12:08,960 --> 01:12:14,320
that there are a few more questions
1842
01:12:11,760 --> 01:12:16,960
in the chat but because we have now
1843
01:12:14,320 --> 01:12:19,520
reached the end of this training session
1844
01:12:16,960 --> 01:12:22,239
i would propose that we also look at
1845
01:12:19,520 --> 01:12:24,800
these questions afterwards and we reply
1846
01:12:22,239 --> 01:12:26,320
to you in writing
1847
01:12:24,800 --> 01:12:28,320
so
1848
01:12:26,320 --> 01:12:30,239
don't worry if you didn't manage to get
1849
01:12:28,320 --> 01:12:31,920
your question answered you will get an
1850
01:12:30,239 --> 01:12:34,400
answer in writing
1851
01:12:31,920 --> 01:12:36,320
we will i will repeat again we will
1852
01:12:34,400 --> 01:12:38,560
share the broadcast
1853
01:12:36,320 --> 01:12:41,040
we will share the recording i should say
1854
01:12:38,560 --> 01:12:44,000
to with all of you and we will also
1855
01:12:41,040 --> 01:12:47,040
share the slides so that you can go over
1856
01:12:44,000 --> 01:12:48,880
them again so with this i just would
1857
01:12:47,040 --> 01:12:51,040
like to thank you again for your
1858
01:12:48,880 --> 01:12:52,239
attention for all your very useful
1859
01:12:51,040 --> 01:12:54,560
questions
1860
01:12:52,239 --> 01:12:57,040
and and i want to thank my colleagues
1861
01:12:54,560 --> 01:12:59,840
delia carlo dunya
1862
01:12:57,040 --> 01:13:01,679
and miguel for all their support and i
1863
01:12:59,840 --> 01:13:04,159
hope you find this
1864
01:13:01,679 --> 01:13:09,560
training session useful and i wish you a
1865
01:13:04,159 --> 01:13:09,560
good day and a good weekend thank you
