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Semelhante a Informa Life Sciences’ Inaugural Conference on e-Submissions
Semelhante a Informa Life Sciences’ Inaugural Conference on e-Submissions (20)
Informa Life Sciences’ Inaugural Conference on e-Submissions
- 1. Informa Life Sciences’ Conference on e-Submissions From paper dossiers to electronic submissions Alain Seront GlaxoSmithKline Biologicals 18-19 October 2011| Zurich, Switzerland
- 2. GlaxoSmithKline Biologicals 1945 Founded as RIT (Recherche et Industrie Thérapeutiques) é 1968 Becomes SmithKline RIT 1989 SmithKline merges with Beecham 2000 GlaxoWellcome and SmithKline Beecham merge GSK Biologicals: the vaccine business of GlaxoSmithkline Over 30 marketed vaccines available worldwide 11.000 employees worldwide / 7000 in the p y Headquarter in Belgium
- 3. GlaxoSmithKline Biologicals Manager of the Document Management and Publishing Team at GlaxoSmithKline Biologicals 10 years in Pharma Regulatory operations R l t ti Publishing e submissions e-submissions (project management) alain.seront@gskbio.com alain seront@gskbio com
- 4. Topics Background Design of the processes and systems for eCTD Overall process Content Plan Structure of the electronic document management system (eDMS) Authoring process Publishing Process Viewing and archiving eCTDs Positive and negative lessons learned eCTD implementation strategy Reusability of documents and submissions Flexibility Systems integration
- 5. BACKGROUND
- 6. Background GlaxoSmithKline GlaxoSmithKline Pharma GlaxoSmithKline Biologicals Early adopter of the eCTD Late adopter of the eCTD
- 7. Background Start eCTD EMEA implementing l mandatory for d f announced new eCTD / e-submissions eCTD NeeS / paper First eCTD in EU – CP 17 products and mandatory for publishing, QC sequence send >600 e-submission b i i and archiving to t EMEA by GSK b sequences iin tools at GSK Bio First for Jan. 2010 Bio worksharing in eCTD eCTD submitted by GSK BIO December February November January October 2008 2009 2009 2010 2011
- 8. DESIGN OF THE PROCESSES & SYSTEMS FOR ECTD
- 9. It’s not only eCTD (and NeeS)! From paper dossiers to electronic submissions? b i i ? or From paper dossier to electronic submissions AND paper submission? Paper submissions are still part of the game!
- 10. Overall process Regulatory Clinical NonClinical Technical Clinical Affairs / Ops Regulatory Regulatory Initiate C t t I iti t 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 from eDMS (following content plan) Publish QC (validators + manual QC following content plan) Submit to authorities Archive
- 11. Overall process Regulatory Clinical NonClinical Technical Clinical Affairs / Ops Regulatory Regulatory Initiate C t t I iti t 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 from eDMS (following content plan) Publish QC (validators + manual QC following content plan) Submit to authorities Archive
- 12. Content plan Excel spreadsheet with macros Purpose List ll d Li t all documents that go in a dossier t th t i d i with their location in the CTD And their order in a specific section Information on lifecycle for each document Documents linked in more than 1 leaf
- 13. Content plan Purpose Help authors to define names for documents and comply with naming conventions For leaf titles For PDF file names Define documents granularity for each product Quality check for dossier managers / publishers
- 14. Content plan Several content plans Generic content plan Product specific content plan Submission specific content plan Dossier specific content plan
- 15. Content plan Several content plans Generic content plan Capture GSK principles for all modules regarding General principles of document granularity Naming conventions (leaf title, PDF file name) Product specific content plan Capture module 3 principles for a specific product Drug substances and drug product presentation Product specific documents granularity and naming conventions
- 16. Content plan Several content plans Submission specific content plan To reflect modules and documents relevant for a submission type, idependently from a product E.g. : PSUR submission g Dossier specific content plan To reflect modules and documents relevant to a specific dossier / submission
- 17. Overall process Regulatory Clinical NonClinical Technical Clinical Affairs / Ops Regulatory Regulatory Initiate C t t I iti t 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 from eDMS (following content plan) Publish QC (validators + manual QC following content plan) Submit to authorities Archive
- 18. Structure of the eDMS Structure of the eDMS Authoring in eDMS Communities Dossier Area
- 19. Structure of the eDMS electronic document management system Templates Communities Dossiers Area Area Area Drug Product Quality Submission Type Clinical V# Variation II/18 M1 publishing tools Registration Management M2 Labeling
- 20. Structure of the eDMS 3 main areas Templates area Templates for most of submission documents Communities area Contains ll th d C t i all the documents from the t f th communities which contributes to the dossier writing (Quality CMC, Safety, Labelling, Clinical, ...) Main storage for “source” documents written for dossiers Each community has its own folder structure to manage it own d its documentst
- 21. Structure of the eDMS 3 main areas Dossiers area Contains all the dossiers Organised by product / submission type / dossier Dossier folder structure: CTD or mirrors the composition of the submitted dossier Populated by linking documents from the p y g Communities Source area for the publishers to build the dossier d i “Where used?”: for each document, in which dossier it has been included
- 22. Authoring Process Take template from templates area Paste into Community area Link into dossier area Start authoring in Community or dossier area C C docu e ts ot dossier or even product CMC: documents not doss e o e e p oduct related authoring in Community area Dossiers Managers: document related to a dossier / submission authoring in dossier area All documents are authored in eDMS
- 23. Overall process Regulatory Clinical NonClinical Technical Clinical Affairs / Ops Regulatory Regulatory Initiate C t t I iti t 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 from eDMS (following content plan) Publish QC (validators + manual QC following content plan) Submit to authorities Archive
- 24. Publishing process eCTD – NeeS for one product eCTD – NeeS for several products Same content of th d i S t t f the dossier e.g. Worksharing submission eCTD – NeeS for several regions Paper only eCTD – N S and paper CTD NeeS d
- 25. Publishing process clone clone eDMS eCTD eCTD eCTD publishing tool publishing tool publishing tool compile compile compile 0004 (eCTD) 0006 (eCTD) 0000 0000 (NeeS) m1 m1 m1 m1 m2 m2 m2 m2 m3 m3 m3 m3 util util util ctd-toc index.xml index.xml index.xml m1-toc index-md5.txt i d d5 t t index-md5.txt index-md5.txt m2-toc m3-toc
- 26. Publishing process eCTD for different regions clone eDMS eCTD eCTD publishing tool publishing tool compile il compile il 0004 (eCTD) 0006 (eCTD) m1 m1 m2 m2 m3 m3 util util index.xml index.xml index-md5.txt index-md5.txt
- 27. Publishing process Paper only eDMS paper publishing tool publish p blish
- 28. Publishing process eCTD and paper import i t eDMS paper eCTD publishing tool publishing tool publish p blish compile 0004 m1 m2 m3 util index.xml index-md5.txt
- 29. Overall process Regulatory Clinical NonClinical Technical Clinical Affairs / Ops Regulatory Regulatory Initiate C t t I iti t 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 from eDMS (following content plan) Publish QC (validators + manual QC following content plan) Submit to authorities Archive
- 30. Viewing and archiving eCTDs publishing tools eCTD viewer 0000 0001 0002 0003 0000 0004 0001 0005 0002 0005 0003 0004 Publishing temporary shared drive eDMS - archiving
- 31. Viewing and archiving eCTDs Specific constraints Current view must be available Historical view must be available In-progress sequence (not archived yet) must be included in viewer Hyperlinks must be functional From the xml backbone to documents Between documents
- 32. LESSONS (+ AND -) LEARNED
- 33. Lessons learned Positive aspects eCTD implementation strategy Reusability of documents and submissions improved Flexibility
- 34. Implementation strategy Implement a system to comply with eCTD technical requirements? Not a lot of return on investment eCTD CTD Focus on implementing all the possibilities that eCTD brings? Focus on how to “use” eCTD use implementation to refine and improve Late adoption our processes and tools? of eCTD
- 35. Implementation strategy e eDMS R eDMS Publishing g Publishing g C Viewing P Viewing T Tracking S Tracking Archiving Archiving D
- 36. Implementation strategy 0004 (eCTD) m1 m2 m3 M util index.xml Y index-md5.txt S eDMS Y Viewing paper S Tracking T Archiving E 0000 (NeeS) M m1 m2 S m3 ctd-toc m1-toc m2-toc m3-toc RPS
- 37. Implementation strategy Implement a system just to comply with eCTD? eCTD as the eDMS / publishing systems? If the standard changes, the systems must changes change eCTD CTD Implement eCTD as one output from the eDMS / publishing systems? Reusability of the systems for other outputs
- 38. Reusability Of documents, allowed by Chosen granularity (lot of small granules) Omit context of use in documents (e g no (e.g. reference to brands, region or type of submission)) Context can be given by Location of d L ti f document i eDMS d i area t in DMS dossier Location of document in published dossier
- 39. Reusability Of dossier Principles 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 dossier d i
- 40. Flexibility Flexibility Changes internal to the company eCTD for new countries (e.g. Switzerland) or new procedures (e.g. MRP) Outsourcing of some activities? Changes from regulatory authorities Worksharing and grouping (Jan. 2010) New validation rules for NeeS and eCTD (Sept 2011) (Sept. eCTD next major version – RPS (some day) Current processes and systems must accommodate these changes
- 41. Lessons learned What could be improved? Systems integration
- 42. Systems integration Repository A Document Reviewing management (lifecycle) Planning Authoring Publish tracking Repository B Review Repository D Archive published dossier Repository C Distribute (authorities / affiliates)
- 43. Systems integration Document Reviewing management (lifecycle) Authoring Publish Review Archive A hi published bli h d dossier Distribute (authorities ( h i i / affiliates)
- 44. Systems integration Management Reviewing (lifecycle) (lif l ) Planning Authoring Publish Review Archive A hi published bli h d dossier Distribute (authorities ( h i i / affiliates)
- 45. Systems integration Management Reviewing (lifecycle) (lif l ) Authoring Publish Review Archive A hi published bli h d dossier Distribute (authorities ( h i i / affiliates) tracking
- 46. Final words Think what eCTD (or any other new standard) could bring to your business t d d) ld b i t b i and not only what is the minimum you need to have to comply with eCTD (or any new standard) y )
- 47. Final words Flexibility… flexibility… flexibility Reusability… reusability Reusability reusability… reusability Integration… integration… integration
- 50. BACK-UP SLIDES
- 51. eDMS and Publishing For each document in eDMS Some attributes are mandatory Automatically used to populate attributes in publishing tools Are included in eCTD backbone PDF table of backbone, contents (for NeeS and paper)
- 52. eDMS and Publishing eDMS Example eCTD NeeS Paper attributes Document name 2.3 - V2011000418 - - - Quality Overall Summary eCTD name Quality Overall Leaf title Entry in PDF ToC Entry in ToC Summary on change h Reference i cross- R f in Reference i cross- R f in manufacturing site references to this references to this document document Output file name qos-v2011000418 File name File name - (qos-v2011000418.pdf) (qos-v2011000418.pdf)
- 53. eDMS and Publishing Those attributes in eDMS Ensure efficiency Attributes introduced and checked once Reuse each time the document is used in a dossier Ensure quality Content of the attributes are defined by the content plan Adherence to eCTD and NeeS naming conventions
- 54. Background GlaxoSmithKline GlaxoSmithKline Pharma GlaxoSmithKline Biologicals Early adopter of the eCTD Late adopter of the eCTD
- 55. Geographical integration of systems Current situation eDMS eDMS Publishing Publishing Viewing Viewing Tracking Tracking Archiving Archiving
- 56. Geographical integration of systems Ideal situation eDMS Publishing Viewing Tracking Archiving
- 57. Geographical integration of systems Would allow publishing around the clock