Chris Holmes Principal, WCI Consulting Ltd
Contents
• Pharmacovigilance (PV) environment • Best Practices Forum • Top 10 issues • Current industry responses • Conclusions
Pharmacovigilance environment
• Move beyond compliance to proactive, medically driven safety risk management
• Constantly evolving regulatory environment with increased enforcement
• Provide overview of, and direct access to, information regarding safety profiles, emerging safety concerns
• Ensure adequate representation in medical governance
• 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