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Informa Life Sciences’ Inaugural Conference on e-Submissions

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Informa Life Sciences’ Inaugural Conference on e-Submissions - October 2011 - Zurich

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Informa Life Sciences’ Inaugural Conference on e-Submissions

  1. 1. Informa Life Sciences’ Conference on e-SubmissionsFrom paper dossiers to electronic submissions Alain Seront GlaxoSmithKline Biologicals 18-19 October 2011| Zurich, Switzerland
  2. 2. GlaxoSmithKline Biologicals1945 Founded as RIT (Recherche et Industrie Thérapeutiques) é1968 Becomes SmithKline RIT1989 SmithKline merges with Beecham2000 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. 3. GlaxoSmithKline BiologicalsManager of the Document Management andPublishing Team at GlaxoSmithKline Biologicals10 years in Pharma Regulatory operations R l t ti Publishing e submissions e-submissions (project management)alain.seront@gskbio.comalain seront@gskbio com
  4. 4. TopicsBackgroundDesign 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 eCTDsPositive and negative lessons learned eCTD implementation strategy Reusability of documents and submissions Flexibility Systems integration
  5. 5. BACKGROUND
  6. 6. Background GlaxoSmithKlineGlaxoSmithKline Pharma GlaxoSmithKline BiologicalsEarly adopter of the eCTD Late adopter of the eCTD
  7. 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 andmandatory for publishing, QC sequence send >600e-submission b i i and archiving to t EMEA by GSK b sequences iin tools at GSK Bio Firstfor Jan. 2010 Bio worksharing in eCTD eCTD submitted by GSK BIO December February November January October 2008 2009 2009 2010 2011
  8. 8. DESIGN OF THEPROCESSES & SYSTEMSFOR ECTD
  9. 9. It’s not only eCTD (and NeeS)!From paper dossiers to electronicsubmissions? b i i ?orFrom paper dossier to electronicsubmissions AND paper submission? Paper submissions are still part of the game!
  10. 10. Overall process Regulatory Clinical NonClinical Technical Clinical Affairs / Ops Regulatory Regulatory Initiate C t t I iti t Content Plan Setup folderstructures in eDMS Authoring in eDMS (communities) Link from eDMS communities to eDMS dossier areaCreate eCTD seq. in publishing toolPopulate eCTD seq. with docs from eDMS (following content plan) Publish QC (validators + manual QC following content plan) Submit to authorities Archive
  11. 11. Overall process Regulatory Clinical NonClinical Technical Clinical Affairs / Ops Regulatory Regulatory Initiate C t t I iti t Content Plan Setup folderstructures in eDMS Authoring in eDMS (communities) Link from eDMS communities to eDMS dossier areaCreate eCTD seq. in publishing toolPopulate eCTD seq. with docs from eDMS (following content plan) Publish QC (validators + manual QC following content plan) Submit to authorities Archive
  12. 12. Content planExcel spreadsheet with macrosPurpose 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. 13. Content planPurpose 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. 14. Content planSeveral content plans Generic content plan Product specific content plan Submission specific content plan Dossier specific content plan
  15. 15. Content planSeveral 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. 16. Content planSeveral 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. 17. Overall process Regulatory Clinical NonClinical Technical Clinical Affairs / Ops Regulatory Regulatory Initiate C t t I iti t Content Plan Setup folderstructures in eDMS Authoring in eDMS (communities) Link from eDMS communities to eDMS dossier areaCreate eCTD seq. in publishing toolPopulate eCTD seq. with docs from eDMS (following content plan) Publish QC (validators + manual QC following content plan) Submit to authorities Archive
  18. 18. Structure of the eDMSStructure of the eDMSAuthoring in eDMSCommunitiesDossier Area
  19. 19. Structure of the eDMS electronic document management systemTemplates Communities Dossiers Area Area Area Drug Product Quality Submission Type Clinical V# Variation II/18 M1 publishing tools Registration Management M2 Labeling
  20. 20. Structure of the eDMS3 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. 21. Structure of the eDMS3 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. 22. AuthoringProcess 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. 23. Overall process Regulatory Clinical NonClinical Technical Clinical Affairs / Ops Regulatory Regulatory Initiate C t t I iti t Content Plan Setup folderstructures in eDMS Authoring in eDMS (communities) Link from eDMS communities to eDMS dossier areaCreate eCTD seq. in publishing toolPopulate eCTD seq. with docs from eDMS (following content plan) Publish QC (validators + manual QC following content plan) Submit to authorities Archive
  24. 24. Publishing processeCTD – NeeS for one producteCTD – NeeS for several products Same content of th d i S t t f the dossier e.g. Worksharing submissioneCTD – NeeS for several regionsPaper onlyeCTD – N S and paper CTD NeeS d
  25. 25. Publishing process clone cloneeDMS 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. 26. Publishing processeCTD 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. 27. Publishing processPaper only eDMS paper publishing tool publish p blish
  28. 28. Publishing processeCTD 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. 29. Overall process Regulatory Clinical NonClinical Technical Clinical Affairs / Ops Regulatory Regulatory Initiate C t t I iti t Content Plan Setup folderstructures in eDMS Authoring in eDMS (communities) Link from eDMS communities to eDMS dossier areaCreate eCTD seq. in publishing toolPopulate eCTD seq. with docs from eDMS (following content plan) Publish QC (validators + manual QC following content plan) Submit to authorities Archive
  30. 30. Viewing and archiving eCTDspublishing tools eCTD viewer 0000 0001 0002 0003 0000 0004 0001 0005 0002 0005 0003 0004 Publishing temporary shared drive eDMS - archiving
  31. 31. Viewing and archiving eCTDsSpecific 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. 32. LESSONS (+ AND -)LEARNED
  33. 33. Lessons learnedPositive aspects eCTD implementation strategy Reusability of documents and submissions improved Flexibility
  34. 34. Implementation strategy Implement a system to comply with eCTD technical requirements? Not a lot of return on investmenteCTD CTD Focus on implementing all the possibilities that eCTD brings? Focus on how to “use” eCTD use implementation to refine and improveLate adoption our processes and tools? of eCTD
  35. 35. Implementation strategye eDMS R eDMS Publishing g Publishing gC Viewing P ViewingT Tracking S Tracking Archiving ArchivingD
  36. 36. Implementation strategy 0004 (eCTD) m1 m2 m3M util index.xmlY index-md5.txtS eDMSY Viewing paperS TrackingT ArchivingE 0000 (NeeS)M m1 m2S m3 ctd-toc m1-toc m2-toc m3-toc RPS
  37. 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 changeeCTD CTD Implement eCTD as one output from the eDMS / publishing systems? Reusability of the systems for other outputs
  38. 38. ReusabilityOf 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. 39. ReusabilityOf 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. 40. FlexibilityFlexibility 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. 41. Lessons learnedWhat could be improved? Systems integration
  42. 42. Systems integration Repository A Document Reviewing management (lifecycle) Planning Authoring Publishtracking Repository B ReviewRepository D Archive published dossier Repository C Distribute (authorities / affiliates)
  43. 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. 44. Systems integration Management Reviewing (lifecycle) (lif l ) PlanningAuthoring Publish Review Archive A hi published bli h d dossier Distribute (authorities ( h i i / affiliates)
  45. 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. 46. Final wordsThink what eCTD (or any other newstandard) could bring to your business t d d) ld b i t b iand not only what is the minimum youneed to have to comply with eCTD (orany new standard) y )
  47. 47. Final words Flexibility… flexibility… flexibilityReusability… reusabilityReusability reusability… reusabilityIntegration… integration… integration
  48. 48. BACK-UP SLIDES
  49. 49. eDMS and PublishingFor 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)
  50. 50. eDMS and Publishing eDMS Example eCTD NeeS Paper attributesDocument name 2.3 - V2011000418 - - - Quality Overall SummaryeCTD 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 documentOutput file name qos-v2011000418 File name File name - (qos-v2011000418.pdf) (qos-v2011000418.pdf)
  51. 51. eDMS and PublishingThose 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
  52. 52. Background GlaxoSmithKlineGlaxoSmithKline Pharma GlaxoSmithKline BiologicalsEarly adopter of the eCTD Late adopter of the eCTD
  53. 53. Geographical integration of systemsCurrent situation eDMS eDMS Publishing Publishing Viewing Viewing Tracking Tracking Archiving Archiving
  54. 54. Geographical integration of systemsIdeal situation eDMS Publishing Viewing Tracking Archiving
  55. 55. Geographical integration of systemsWould allow publishing around the clock

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