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Session 3, Track C: Trust but Verify - Building and Governing High-Performing PV Partnerships
Session Chair(s)
Riti Singh, PharmD, MBA
National Director - Scientific Affairs, Regulatory and Quality (SARQ), Bayshore Healthcare (Bayshore Specialty Rx Ltd.), Canada
Mei Lam, BSN, RN
Associate Director Consumer Safety Regions Americas, Haleon, Canada
Akinwumi Akintoye
Manager, Quality Audits, Bayshore Specialty Rx Ltd., Canada
As patient engagement models evolve—spanning marketing programs, digital platforms, and clinical initiatives—pharmacovigilance oversight is becoming increasingly fragmented and complex. This session explores how MAHs can retain control and accountability while navigating shared responsibilities with third-party vendors. It dives into building fit-for-purpose vendor models, strengthening oversight frameworks, and ensuring continuous inspection readiness through effective self-inspection and audit strategies. Ultimately, it challenges organizations to rethink how they maintain a state of control in an increasingly outsourced, interconnected PV ecosystem.
Learning Objective : At the conclusion of this session, participants should be able to: - Identify patient engagement program models as intake sources for safety information and educate on baseline requirements for GVP Compliance
- Apply practical approaches to select, qualify and oversee PV vendors including performance monitoring and risk-based oversight
- Implement self-inspection and audit practices to maintain inspection readiness and control of the PV system
Speaker(s)
Representative Invited
Country Safety Head- Associate Director, Teva Pharmaceuticals, Canada
PV Vendor Qualification and Governance - Qualification Process, Parameters and Tools
Representative Invited
Head of Medical Governance, Operations and Patient Access, Bayer, Canada
Maintaining High-Performing PV Partnerships - How to Maintain PV Vendor Oversight to Ensure Compliance with GVP Regulations