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Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
Building a link between ectd and xevmpd
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Building a link between ectd and xevmpd

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Describing the role of XEVMPD/ IDMP in context of the regulatory environment and explaining the link with information managed within the eCTD and under GMP.

Describing the role of XEVMPD/ IDMP in context of the regulatory environment and explaining the link with information managed within the eCTD and under GMP.

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  • 1. Building a link between eCTDand XEVMPDSamarind Webinar – 21st June 2013Michiel StamQdossier B.V.
  • 2. 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 2AgendaWhy new pharmacovigilance regulation?• Improve signal detection by more specifically attribute adverseevents to medicines• XEVMPD is just one of the tools for pharmacovigilanceOther (Pharmacovigilance) documentation needs to beconsidered in this context• Overview of all kind of structured information requested in the EUWhat to learn• Conclusions
  • 3. Need to improve public healthMedicines save lives and relieve suffering, but….• Can also cause side effects• 5% of all hospital admissions• Nearly 200,000 deaths per year in the EUPromote and protect public health by• Reducing burden of side effects• Optimizing the use of medicines21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 3
  • 4. 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 4ConsideringData collection and managementBenefit-Risk assessmentSignal detectionSafety Issue evaluationRegulatory actionCommunicationAudit
  • 5. ImpactsActors• EMA (PRAC)• NCAs• Pharmaceutical companies• Patients and Health CareProfessionalsEntire product lifecycleEstimated to savebetween 500 and 5000lives per year• savings to society of €250-2,500 million/year21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 5
  • 6. How?All MSs introduce direct consumer reportingEstablishment of PhVg Risk Assessment Committee(PRAC)Robust EU decision makingEngaging patients and health care professionalsScience basedRisk proportionateGreater proactivityReduced duplication and greater efficiencyIncreased transparency and better information21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 6
  • 7. Direct consumer reporting21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 7
  • 8. Direct consumer reporting21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 8
  • 9. TasksIndustry:• Maintain PhVg System Master File• Regulatory documents in eCTD (incl. cover letter, application form)• PSURs evaluate benefit-risk; not only focus on safety• Modular RMP• Summary of PhVg System master filePRAC to provide expert advice on safety and benefit-riskTransparency and communication• Coordination of PhVg inspections• Routine PhVg audits• Better funding for public health protectionBetter definition of intervening medicinal products• XEVMPD (To be submitted by XEVPRMs)21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 9
  • 10. SFDA campaign food additives21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 10
  • 11. 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 11Marketing License through CTDICSRsbyE2BPhVgSystemMasterFile byGVPICSRsManu-facturingLicensethroughGMPWWMAstatusRMPInterfacePatient benefit/risk ratio
  • 12. EU Envelope21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 12
  • 13. Cover letter Initial MAA + Variations21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 13
  • 14. Cover letter Post-authorisation commitments21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 14
  • 15. Application form 121-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 15
  • 16. Application form – 2, etc21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 16
  • 17. RMP Part I “Product overview”Active substance information:• active substance(s); ATC code; name MAH or applicant; date andcountry of first authorisation; date and country of first launchworldwide; number of medicinal product(s) to which this RMP refers.Administrative information on the RMP:• DLP RMP; date submitted and version No.; list of RMP modules(incl. date and version No.)• for each medicinal product included in the RMP:• authorisation procedure; invented name(s) in EEA;• brief description of the product (incl. chemical class)• indications:• dosage:• pharmaceutical forms and strengths:21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 17
  • 18. RMP part II “Safety specification”Module SI Epidemiology of the indication(s) and targetpopulation(s)Module SII Non-clinical part of the safety specificationModule SIII Clinical trial exposureModule SIV Populations not studied in clinical trialsModule SV Post-authorisation experienceModule SVI Additional EU requirements for the safetyspecificationModule SVII Identified and potential risksModule SVIII Summary of the safety concerns21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 18
  • 19. RMP Interface ToC21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 19
  • 20. RMP interface – Administrative21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 20
  • 21. RMP interface – Product21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 21
  • 22. RMP interface – Indications21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 22
  • 23. RMP interface – Risks21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 23
  • 24. RMP interface – Interactions21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 24
  • 25. RMP interface – Missing information21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 25
  • 26. New PSUR - mandated since 10 Jan 2013Part of a regulatory submission (e)CTD Module 5.3.6Benefit-risk (not only safety) and cumulative• Based on AEs instead of ADRs• More structured evaluation based on cumulative data• No summary bridging reports or addendum reports• No acceptance of multiple 6 monthly reportsAssessment leads to automatic regulatory action• variation, suspension, revocationSubmission frequency will be variable (based on risks)EMA list of substances with submission dates• Union Reference Dates and periodicity of submissions (EURD) list21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 26
  • 27. (EURD) European Union reference date21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 27
  • 28. PhVg System Master File (on file only,replacing DDPS in dossiers)General details• EV code or local code (XEVMPD)• Name of MAH, the MAH of theQPPV (if different), relevantQPPV 3rd party (if applicable)• Name of concerned MAH(s)• List of PhVg system master fileswith different PhVg system• Date of preparation/last updateMAH organizationSources of safety dataComputerized systems anddatabasesQPPV particularsPhVg processesPhVg system performanceQuality systemRelated documents• List of products covered by thisPhVg MF, incl.• MA #, Rapporteur or RMS, marketpresence• Other (non-EU) territories• Specific safety monitoringrequirements• Roles and Responsibilities if 3rdparties are involved21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 28Upon request, a Change control logbook, versions and archiving details may be requested
  • 29. Summary of PSMF (mandated >July 2015)Replacing the DDPS in dossiersProof that Company has a QPPV at its disposalStatement of pharmacovigilance competenceMember states in which QPPV resides and carries out histasksQPPV contact detailsPSMF location (Code as in XEVMPD)21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 29
  • 30. XEVMPD database filled by industry, ownedby EMA (mandated >2 July 2012)Organization (MAH and QPPV details)ATC code (as in SmPC)Pharmaceutical Form (EMA vocabulary)Route of administration (EMA vocabulary)Substance (EMA vocabulary)• Structured substance information not mandated yet• Would have much more dataProduct details• Next slideAttachment• corresponding SmPC for verificationQPPV details21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 30
  • 31. Example of Product details21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 31
  • 32. ConclusionWhat to learn from all these formats and formsrequesting structured information?21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 32
  • 33. Conclusion CMC its relation to XEVMPDRegulatory information should be reused at variouseCTD documents, RMP interface and XEVMPD/IDMPHow?• Develop internal standards• Leverage (do not copy!) from existing standards• Inherit values across disciplines, documents and tools• Define mapping and automate correlation to other standards• Envelope, cover letter, application form, XEVMPD, IDMP,Module 3, etc.Manage properly the regional aliases and translations, to supportbeyond the EU too21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 33
  • 34. Thank you !Questions?

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