Post on 26-Jun-2015
description
Informa Life Sciences’ Conference on e-Submissions
From paper dossiers to electronic submissionssubmissions
Alain SerontAlain SerontGlaxoSmithKline Biologicals
18-19 October 2011| Zurich, Switzerland
GlaxoSmithKline Biologicals
é19451945
19681968
Founded as RIT (Recherche et Industrie Thérapeutiques)
Becomes SmithKline RIT
19891989
20002000
SmithKline merges with Beecham
GlaxoWellcome and SmithKline Beecham merge20002000 GlaxoWellcome and SmithKline Beecham merge
GSK Biologicals: the vaccine business of GlaxoSmithkline
Over 30 marketed vaccines available worldwide
11.000 employees worldwide / 7000 in thep y /
Headquarter in Belgium
GlaxoSmithKline Biologicals
Manager of the Document Management and Publishing Team at GlaxoSmithKline BiologicalsPublishing Team at GlaxoSmithKline Biologicals
10 years in PharmaR l t tiRegulatory operationsPublishinge-submissions (project management)e submissions (project management)
alain seront@gskbio comalain.seront@gskbio.com
Topics
Background
Design of the processes and systems for eCTDDesign of the processes and systems for eCTD
Overall process
Content PlanContent Plan
Structure of the electronic document management system (eDMS)
Authoring processAuthoring process
Publishing Process
Viewing and archiving eCTDsViewing and archiving eCTDs
Positive and negative lessons learned
eCTD implementation strategyeCTD implementation strategy
Reusability of documents and submissions
FlexibilityFlexibility
Systems integration
BACKGROUND
Background
GlaxoSmithKline
GlaxoSmithKline BiologicalsGlaxoSmithKline Pharma
Early adopter of the eCTD Late adopter of the eCTD
Background
Start l
eCTDd fEMEA
announced eCTD
mandatory for b i i
implementing new eCTD / NeeS / paper publishing, QC and archiving
First eCTDsequence send
t EMEA b GSK
mandatory for e-submissions
in EU – CP 17 products and >600
ie-submission for Jan. 2010
and archiving tools at GSK Bio
to EMEA by GSK Bio
First worksharing in eCTD submitted
by GSK BIO
sequences in eCTD
December2008
February2009
November2009
January2010
October2011
DESIGN OF THE PROCESSES & SYSTEMS PROCESSES & SYSTEMS FOR ECTDFOR ECTD
It’s not only eCTD (and NeeS)!
From paper dossiers to electronic b i i ?submissions?
oror
From paper dossier to electronic submissions AND paper submission?
Paper submissions are still part of thePaper submissions are still part of the game!
Overall processRegulatory
Affairs / OpsClinical
RegulatoryNonClinical Technical
RegulatoryClinical
I iti t C t tInitiate Content Plan
Setup folder structures in eDMS
Authoring in eDMS (communities)
Link from eDMS communities to eDMS dossier area
Create eCTD seq. in publishing tool
Populate eCTD seq. with docs fromwith docs from
eDMS (following content plan)
Publish
QC (validators + manual QC following content plan)
Submit to authorities
Archive
Overall processRegulatory
Affairs / OpsClinical
RegulatoryNonClinical Technical
RegulatoryClinical
I iti t C t tInitiate Content Plan
Setup folder structures in eDMS
Authoring in eDMS (communities)
Link from eDMS communities to eDMS dossier area
Create eCTD seq. in publishing tool
Populate eCTD seq. with docs fromwith docs from
eDMS (following content plan)
Publish
QC (validators + manual QC following content plan)
Submit to authorities
Archive
Content plan
Excel spreadsheet with macros
PurposeLi t ll d t th t i d iList all documents that go in a dossier
with their location in the CTDAnd their order in a specific section
Information on lifecycle for each document
Documents linked in more than 1 leaf
Content plan
PurposeHelp authors to define names for documents and comply with naming conventions
For leaf titlesFor PDF file names
Define documents granularity for each product
Quality check for dossier managers /Quality check for dossier managers / publishers
Content plan
Several content plansGeneric content plan
Product specific content planProduct specific content plan
Submission specific content plan
Dossier specific content plan
Content plan
Several content plansGeneric content plan
Capture GSK principles for all modules regardingCapture GSK principles for all modules regardingGeneral principles of document granularityNaming conventions (leaf title, PDF file name)
Product specific content plan
Capture module 3 principles for a specificCapture module 3 principles for a specific product
Drug substances and drug product presentationProduct specific documents granularity and naming
conventions
Content plan
Several content plansSubmission specific content plan
To reflect modules and documents relevant for aTo reflect modules and documents relevant for a submission type, idependently from a product
E.g. : PSUR submissiongDossier specific content plan
To reflect modules and documents relevant to aTo reflect modules and documents relevant to a specific dossier / submission
Overall processRegulatory
Affairs / OpsClinical
RegulatoryNonClinical Technical
RegulatoryClinical
I iti t C t tInitiate Content Plan
Setup folder structures in eDMS
Authoring in eDMS (communities)
Link from eDMS communities to eDMS dossier area
Create eCTD seq. in publishing tool
Populate eCTD seq. with docs fromwith docs from
eDMS (following content plan)
Publish
QC (validators + manual QC following content plan)
Submit to authorities
Archive
Structure of the eDMS
Structure of the eDMS
Authoring in eDMS
Communities
Dossier AreaDossier Area
Structure of the eDMS
Communities Dossiers Area
electronic document management systemTemplates Communities
Area
Quality
Dossiers Area
Drug Product
Templates Area
Submission Type
Clinical V# Variation II/18
M1 publishing tools
Registration Management
M2
Labeling
Structure of the eDMS
3 main areasTemplates area
Templates for most of submission documentsTemplates for most of submission documentsCommunities area
C t i ll th d t f thContains all the documents from the communities which contributes to the dossier writing (Quality CMC, Safety, Labelling, Clinical,writing (Quality CMC, Safety, Labelling, Clinical, ...)
Main storage for “source” documents written for dossiers
Each community has its own folder structure to it d tmanage its own documents
Structure of the eDMS
3 main areasDossiers area
Contains all the dossiersContains all the dossiersOrganised by product / submission type / dossierDossier folder structure: CTD or mirrors theDossier folder structure: CTD or mirrors the
composition of the submitted dossierPopulated by linking documents from the p y g
CommunitiesSource area for the publishers to build the
d idossier“Where used?”: for each document, in which
dossier it has been includeddossier it has been included
Authoring
ProcessTake template from templates area
Paste into Community areaPaste into Community area
Link into dossier area
Start authoring in Community or dossier area
CMC: documents not dossier or even product C C docu e ts ot doss e o e e p oductrelated authoring in Community area
Dossiers Managers: document related to a dossier / submission authoring in dossier area
All documents are authored in eDMS
Overall processRegulatory
Affairs / OpsClinical
RegulatoryNonClinical Technical
RegulatoryClinical
I iti t C t tInitiate Content Plan
Setup folder structures in eDMS
Authoring in eDMS (communities)
Link from eDMS communities to eDMS dossier area
Create eCTD seq. in publishing tool
Populate eCTD seq. with docs fromwith docs from
eDMS (following content plan)
Publish
QC (validators + manual QC following content plan)
Submit to authorities
Archive
Publishing process
eCTD – NeeS for one product
eCTD – NeeS for several productsS t t f th d iSame content of the dossier
e.g. Worksharing submission
eCTD – NeeS for several regions
Paper only
CTD N S deCTD – NeeS and paper
Publishing process
clone clone
eCTDpublishing tool
eCTDpublishing tool eCTD
publishing tool
eDMS
compile compile compile
0000 (NeeS)
m1
m2
0004 (eCTD)
m1
m2
0006 (eCTD)
m1
m2
0000
m1
m2
m3
m1-toc
ctd-toc
m3
util
index.xml
i d d5 t t
util
m3
index.xml
m3
util
index.xml
m2-toc
m3-toc
index-md5.txt index-md5.txt index-md5.txt
Publishing process
eCTD for different regions clone
eDMS
eCTDpublishing tool
eCTDpublishing tool
il ilcompile
0004 (eCTD)
compile
0006 (eCTD)
m1
m2
m3
util
m1
m2
m3
utilutil
index.xml
index-md5.txt
util
index.xml
index-md5.txt
Publishing process
Paper only
paper
eDMS
paperpublishing tool
p blishpublish
Publishing process
eCTD and paperi timport
eDMS
eCTDpublishing tool
paperpublishing tool
p blish
0004
compile publish
m1
m2
m3
util
index.xml
index-md5.txt
Overall processRegulatory
Affairs / OpsClinical
RegulatoryNonClinical Technical
RegulatoryClinical
I iti t C t tInitiate Content Plan
Setup folder structures in eDMS
Authoring in eDMS (communities)
Link from eDMS communities to eDMS dossier area
Create eCTD seq. in publishing tool
Populate eCTD seq. with docs fromwith docs from
eDMS (following content plan)
Publish
QC (validators + manual QC following content plan)
Submit to authorities
Archive
Viewing and archiving eCTDs
eCTD viewerpublishing tools
0001
0000
0001
00000004
0003
0002
0004
0003
0002
0001
0005
0005
0004
eDMS - archivingPublishing temporary
shared drive eDMS - archiving
Viewing and archiving eCTDs
Specific constraintsCurrent view must be available
Historical view must be availableHistorical view must be available
In-progress sequence (not archived yet) must be included in viewerbe included in viewer
Hyperlinks must be functional
From the xml backbone to documentsBetween documents
LESSONS (+ AND -) LEARNEDLEARNED
Lessons learned
Positive aspectseCTD implementation strategy
Reusability of documents and submissionsReusability of documents and submissions improved
FlexibilityFlexibility
Implementation strategy
Implement a system to comply with eCTD technical requirements?
Not a lot of return on investment
CTDeCTDFocus on implementing all theFocus on implementing all the possibilities that eCTD brings?
Focus on how to “use” eCTDFocus on how to use eCTDimplementation to refine and improve our processes and tools?Late adoption our processes and tools?
of eCTD
Implementation strategy
eC
eDMSPublishing
RP
eDMSPublishingC
Tg
ViewingTracking
PS
gViewingTracking
D Archiving Archiving
Implementation strategy
0004 (eCTD)m1
MY
m1m2m3utilindex.xmlY
SY
eDMSViewing
index-md5.txt
paperYSTE
ViewingTrackingArchiving
paper
EMS
0000 (NeeS)m1m2m3
m1-tocctd-toc
m2-tocm3-toc
RPS
Implementation strategy
Implement a system just to comply with eCTD? eCTD as the eDMS / publishingeCTD? eCTD as the eDMS / publishing systems?
If the standard changes the systems mustIf the standard changes, the systems must change
CTDeCTDImplement eCTD as one output from the eDMS / publishing systems?
Reusability of the systems for other outputs
Reusability
Of documents, allowed byChosen granularity (lot of small granules)
Omit context of use in documents (e g noOmit context of use in documents (e.g. no reference to brands, region or type of submission))
Context can be given by
L ti f d t i DMS d iLocation of document in eDMS dossier areaLocation of document in published dossier
Reusability
Of dossierPrinciples
Start with one assembly (generally eCTD / NeeS)Start with one assembly (generally eCTD / NeeS)Import documents from eDMS to publishing tool
(most publishing time consuming task)( p g g )Reuse (clone) the first assembly for
Another product (e.g. Worksharing)Another region (e.g. from EMA to Switzerland)Another format (e.g. from eCTD to paper)
Make the most out of the first published d idossier
Flexibility
Flexibility
Changes internal to the companyeCTD for new countries (e.g. Switzerland) or new
procedures (e.g. MRP)Outsourcing of some activities?
Changes from regulatory authoritiesChanges from regulatory authoritiesWorksharing and grouping (Jan. 2010)New validation rules for NeeS and eCTD (Sept 2011)New validation rules for NeeS and eCTD (Sept. 2011)eCTD next major version – RPS (some day)
Current processes and systems must accommodate these changesaccommodate these changes
Lessons learned
What could be improved?Systems integration
Systems integration
Repository A
Document management
(lifecycle)Reviewing
Planning
PublishAuthoring
Repository Btracking
Repository DRepository C
Review published
dossierArchive
Distribute (authorities / affiliates)
Systems integration
Document managementReviewing management
(lifecycle)Reviewing
PublishAuthoring
Review bli h dA hi published
dossier
Distribute ( h i i
Archive
(authorities / affiliates)
Systems integration
Management (lif l )Reviewing (lifecycle)Reviewing
Planning
PublishAuthoring
Review bli h dA hi published
dossier
Distribute ( h i i
Archive
(authorities / affiliates)
Systems integration
Management (lif l )Reviewing (lifecycle)Reviewing
PublishAuthoring
Review bli h dA hi published
dossier
Distribute ( h i i
Archive
(authorities / affiliates)
tracking
Final words
Think what eCTD (or any other new t d d) ld b i t b istandard) could bring to your business
and not only what is the minimum you need to have to comply with eCTD (or any new standard)y )
Final words
Flexibility… flexibility… flexibility
Reusability reusability reusabilityReusability… reusability… reusability
Integration… integration… integration
BACK-UP SLIDES
eDMS and Publishing
For each document in eDMSSome attributes are mandatory
Automatically used to populate attributes inAutomatically used to populate attributes in publishing tools
Are included in eCTD backbone PDF table ofAre included in eCTD backbone, PDF table of contents (for NeeS and paper)
eDMS and Publishing
eDMS Example eCTD NeeS PapereDMSattributes
Example eCTD NeeS Paper
Document name 2.3 - V2011000418 Quality Overall
- - -Quality Overall Summary
eCTD name Quality OverallSummary on h
Leaf title
R f i
Entry in PDF ToC
R f i
Entry in ToC
change manufacturing site
Reference in cross-references to this document
Reference in cross-references to this document
Output file name qos-v2011000418 File name(qos-v2011000418.pdf)
File name(qos-v2011000418.pdf)
-
eDMS and Publishing
Those attributes in eDMSEnsure efficiency
Attributes introduced and checked onceAttributes introduced and checked onceReuse each time the document is used in a
dossierEnsure quality
Content of the attributes are defined by theContent of the attributes are defined by the content plan
Adherence to eCTD and NeeS naming Adherence to eCTD and NeeS naming conventions
Background
GlaxoSmithKline
GlaxoSmithKline BiologicalsGlaxoSmithKline Pharma
Early adopter of the eCTD Late adopter of the eCTD
Geographical integration of systems
Current situation
eDMSPublishing
eDMSPublishingPublishing
ViewingTracking
PublishingViewingTrackingTracking
ArchivingTrackingArchiving
Geographical integration of systems
Ideal situation
eDMSPublishingPublishingViewingTrackingTrackingArchiving
Geographical integration of systems
Would allow publishing around the clock