Pharmacovigilance Post July 2012 The new frontier

Transcription

1 Pharmacovigilance Post July 2012 The new frontier Colleen Walsh Head, Safety and Benefit Risk Management Quality, Biogen Idec 26th Annual EuroMeeting March 2014 ACV, Vienna Austria

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3 Agenda A Global Pharmacovigilance System The Final Product Versus Getting There Goals of the Global System Success Factors A Biogen Idec Case Study Solutions (at least some)

4 Safety Headlines and Warning Letters EMA Slams xxx Over Extensive Safety Reporting 'Deficiencies' FDA WARNING LETTER xxx The legislation is the biggest change to the regulation of human medicines in the European Union (EU) since It has significant implications for applicants and holders of EU marketing authorisations. EMA Website, 4

5 A Global Pharmacovigilance System Global PV system Global availability of safety data Sounds great! 5

6 A Global Pharmacovigilance System Robust and mature PV System and Processes Getting there 6

7 Goals of Global PV System & New Legislation Provide clear roles and responsibilities for all parties to enable robust and rapid decision-making Strengthen post-authorisation regulation Reduce duplication and improve efficiency Science based integrate benefit and risk Increase transparency, harmonisation, and patient involvement IMPROVE OUR ABILITY TO ENSURE AND ENHANCE PATIENT SAFETY!! 7

8 Success Factors for Implementation Communication Communication to concerned functional areas regarding legislation and associated ONGOING activities Reduction in duplicative efforts and streamlined decision making with all stakeholders at the table Harmonization (to the extent possible) Resources Not resource-neutral human and technological resource requirements New PV Legislation means: increased dedicated office of the QPPV & Deputy QPPV increased reporting requirements increased PSUR and RMP requirements dedicated support of the PSMF and Pharmacovigilance Quality system 8

9 Success Factors for Implementation Regulatory Clinical Legal IT Safety Affiliates and Distributors Quality Commercial Quality 9

10 Biogen Idec July 2012 Affiliates and distributors in multiple countries with widely different regulatory landscapes, processes and staff Fragmented understanding of local contract and vendor management practices Studies tracked (maybe) in multiple systems Different quality organisations responsible for audits 10

11 Affiliates and Distributors Safety Designated Staff but not Safety people Delegated/outsourced PV services in most circumstances Nature, location, and currency of contracts Resource and training model Process documents (local PV SOPs) Inspections and audits 11

12 Affiliates and Distributors Steps Taken Bi-annual affiliate and distributor meeting where PV information and PV legislative requirements are discussed/shared QPPV Monthly report completed by Safety Designated Staff at affiliates and distributors with key PV information feeds into PSMF and may trigger update Data reviewed by central team and verification/follow-up conducted by Safety Affiliate training module for PV activities established, inclusive of relevant safety-related SOPs Affiliate specific SOP detailing safety requirements 12

13 Audits Multiple audit teams with multiple different Trackwise workflows No common methodology for documenting audit findings related to safety Understanding of which entities and vendors need auditing and application of a risk-based approach Expertise of auditing staff to conduct PV audits 13

14 Audits Steps Taken Establishment of PV Oversight Committee with attendance from all audit teams New Trackwise selections to allow common tracking and methodology for audit tracking related to PV Cross-training of audit staff on PV legislation and requirements; participation of Safety in audits Harmonization of audit categorizations and risk Assessment amongst groups 14

15 Contracts and Studies Standard PV language not in contract templates or incorporated into contracts Management of new PV legislation requirements with corporate partners Vendor identification and qualification across Biogen Idec is not proceduralized How are ongoing studies tracked and in which systems? 15

16 Contracts and Studies Steps Taken Negotiated updates to Safety Data Exchange Agreements to ensure agreement that relevant sections of the PSMF will be shared and can be made available to a competent authority in the event of inspection Ongoing work with Commercial and Legal to standardize and implement contract language Increased collaboration on vendor selection and checklist for qualification Identification of systems of record for different study types 16

17 Technology Can Help QPPV Dashboard with relevant feeds from systems PSMF is a sub-set of the data Cross-functional contribution 17

18 Technology Can Help QPPV Dashboard with relevant feeds from systems PSMF is a sub-set of the data Cross-functional contribution 18

19 Summary Significant challenges still exist, but improvements have been made A global PV system is not static it requires ongoing review and adjustment Technology can be your friend, if well-thought out and implemented correctly New pharmacovigilance legislation is a marathon, and not a sprint, for public health - Dr Peter Arlett, Head, Pharmacovigilance and Risk Management, EMA 19