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Chris Holmes Principal, WCI Consulting Ltd

Pharmacovigilance and Drug Safety: Top 10 Issues facing Compliance and Legal Pharmaceutical Regulatory Compliance Congress and Best Practices Forum November 8 th 2007 Washington DC. Chris Holmes Principal, WCI Consulting Ltd. Contents. Pharmacovigilance (PV) environment Best Practices Forum

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Chris Holmes Principal, WCI Consulting Ltd

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  1. Pharmacovigilance and Drug Safety: Top 10 Issues facing Compliance and LegalPharmaceutical Regulatory Compliance Congress and Best Practices ForumNovember 8th 2007Washington DC Chris Holmes Principal, WCI Consulting Ltd

  2. Contents • Pharmacovigilance (PV) environment • Best Practices Forum • Top 10 issues • Current industry responses • Conclusions

  3. Pharmacovigilance environment • Move beyond compliance to proactive, medically driven safety risk management • Constantly evolving regulatory environment with increased enforcement • Increased interest in drug safety by stakeholders, desire for more transparency • Increasing workload

  4. Industry response to current environment Future Existing

  5. An Industry Forum has benchmarked current practices and developed future practices • 12 large pharmaceutical and biotechnology companies, since 2001 • Heads of Pharmacovigilance • 26 medium sized companies, inc. Rx, OTC, Devices, Generics • Heads of Pharmacovigilance • 12 large and medium pharmaceutical companies • In-house lawyers

  6. Top 10 PV Issues* • QP-PV role and responsibilities • Contractual arrangements • Governance & Quality Management System • Increased enforcement of Regulations • Formalised Signal Management process • Submission of Risk Management Plans (RMPs) • Developing RMPs across product lifecycle • Aligning PV organisation to enable proactive safety • Individual reporting of ICSRs • Maintaining efficient PV process *Source: pvnet Members, not prioritized

  7. 1. QP-PV role and responsibilitiesClarified in EU Volume 9a, January 2007 • Establish/maintain/manage MAH PV system • Overview of safety profiles, emerging safety concerns • Single contact point for Authorities • Ensure execution of PV obligations: • collection of ADRs at one point in the EU • preparation of reports e.g. PSUR, PASS • continuous post-authorization PV evaluation • Ensure that requests from Authorities are answered fully & promptly

  8. 1. QP-PV role and responsibilitiesIndustry Responsibilities have been clarified in Vol. 9a • Provide overview of, and direct access to, information regarding safety profiles, emerging safety concerns • Ensure adequate representation in medical governance • Assign sufficient authority to actively manage PV system • Develop Performance Mgt to support safety objectives • Increase employee awareness of safety responsibilities, ensure effective mechanisms in place to enable issues to be captured

  9. 2. Contractual arrangements • MAH must have “detailed and clear documented contractual arrangements” in place • MAH must provide authorities with “information on such arrangements” • Closer collaboration with legal and commercial functions required for compliance • Defined process for early involvement of PV in portfolio decisions and due diligence

  10. 3. Governance & Quality Management System • Detailed Description of Pharmacovigilance System (DDPS) required for submissions in EU • More transparency of how MAH PV system works • Template based on Volume 9a expectations • Emerging good practice, key document for Inspections • Need to align and simplify SOPs across PV and operating companies • Create ‘PV Handbook’ for inspection readiness in all affiliates • Establish Operational Risk Management framework • Proactive, systematic approach to identifying and mitigating compliance risks

  11. 3. Single global Quality Management SystemOperations & Compliance framework Process People Governance Structure Technology F F F E E E C C C R R R Failure , Effect, Cause, Risk index

  12. 4. Increased enforcement of Regulations • Recent shift towards stricter enforcement of stricter EU rules • EU inspections becoming routine • Each Member State responsible for inspections • Need for clear and consistent inspection standards • Need to keep abreast of ‘Hot Topics’ as inspection standards and focus varies • New EU Penalties legislation (July, 2007) • Applies to centrally authorized products • Financial penalties to MAHs in respect of infringements • Financial risk associated with non-compliance: up to 5% of total EU annual turnover per annum

  13. 5. Formalised signal management processes • Signal Management becoming more proactive and formalised • pvnet benchmark data shows maturing approach pvconnect pvnet

  14. 5. Formalised signal management processesBenchmark findings

  15. 5. Formalised signal management processesIndustry responses • Signal detection SOPs integrated into Safety Risk Management processes • Consistent responsibilities and accountability for signal detection and management, especially between pre- and post-marketing • Benefit-risk evaluation procedures documented and clear accountability determined • Vol 9a: “The MAH shall forthwith inform the authorities of any other new information which might influence the evaluation of benefits and risks of the medicinal product concerned” • Industry suggestion: decision tree based on public health impact • Perform proactive internal audits (Regulators are auditing signal detection processes)

  16. 6. Submission of Risk Management Plans • Obligation to submit an EU-Risk Management Plan (RMP) • Application for a new MA (new active substance) • Application for significant change in a MA (new dosage form) • On request of Competent Authority (pre- and post authorization) • On initiative of Applicant/MAH (when “safety concern” identified) • EU and US requirements similar in practical application • companies tending to be driven by EU requirements as US is currently less onerous • Monitoring is key* • 83% of RMPs have proposed studies, only 9% reliant on standard PV alone (with no proposal for additional studies or other actions) • Of the proposed studies, a third had not provided an update where one was expected and additional third had not yet started the studies • MHRA and EMEA considering enforcement mechanisms • * source: MHRA (ISoP Annual Conference Oct 2007)

  17. 7. Development of lifecycle Safety Risk Management • Drive towards more proactive, systematic approach to identifying potential safety concerns • FDAAA grants FDA sweeping new authority to require: • Post-marketing studies and clinical trials • Safety labeling changes • Risk evaluation and mitigation strategies (REMS) • Companies are formalising risk management activities earlier in the product lifecycle (pvnet) • PV is generally accountable for safety risk management activity

  18. The development of RMPs is currently largely driven by regulatory needs in EUSource: pvnet survey • Only 1 company has a finalised SOP for RMP development, though 4 more have them in draft • Responsibility for monitoring implementation and effectiveness is PV in 4 companies and a mix of functions in others e.g. clinical

  19. 7. Development of lifecycle Safety Risk MgtIndustry responses • Define risk mgt approach from First-In-Man or earlier and throughout lifecycle: • Formalise processes and tools • Implement Safety Management Teams for Clinical Development Projects (see CIOMS VI) • Define responsibilities for risk identification, mitigation, monitoring of implementation and effectiveness • Ensure consistent global communication on medical safety risks • Ensure a single safety risk management plan exists for all development and key marketed products

  20. 8. Aligning PV organisation to enable proactive safety • Increase employee awareness of safety responsibilities • Training Curricula & toolbox for all employees • Attract and retain high quality competent resources • Improved recruitment & assessment process • Career Path alignment with key functions e.g. Clinical • Improved capability e.g. safety risk mgt, epidemiology • PV competency framework • Balance workload requirements and maintain compliance • Define and implement new roles with clear responsibilities • Implement capacity planning process

  21. 9. Expedited Reporting of Individual Case Safety Reports • Clock for expedited reporting: starts “Day 0” as soon as the minimum information has been received by: • Any personnel of the MAH or • Any organization having a contractual arrangement with the MAH, including CROs, marketing partners, medical representatives etc • Partner agreements impacted and will need reviewing to ensure that they meet new standards • Impact on process metrics and other compliance measures

  22. 10. Maintain efficient PV process • Efficient routine PV process are required to manage growing scope and volume of data • pvnet: avg 10% increase in ADR volume for last 7 years • pvnet data shows increase in productivity, data quality compliance and increased investment in proactive safety surveillance • pvnet: 2005 v 2006 (12 of Top 25 Pharmacos) • 10% increase in productivity • 30% increase in ‘Scientists’ effort on routine PV, corresponding reduction in Physician and Data Processor effort. • 15% increase in signals generated by internal process (rather than notified by external agencies)

  23. 10. Maintain efficient PV process • Simplify global routine PV processes • Align global roles and responsibilities, strengthen links with affiliates • Harmonise product International Birth Dates to streamline PSUR processes • Improve automation • Automate ADR data entry (e.g. call centre, key affiliates) • Run automatic quantitative analysis for signals • Automatic PSUR compilation

  24. Imperatives • Understand all potential compliance exposures as inter-related • View Drug Safety, Medical Affairs, and Quality Operations exposure from an integrated perspective • Align approach to policies, QMS, training and audits • Review global infrastructure for PV and partner functions • Ensure in-house legal counsel support to PV

  25. Thank you Chris Holmes WCI Consulting Ltd + 44 7785 280043 chris.holmes@wcigroup.com

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