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戻る Agenda
Session 9: Pharmacovigilance Agreements (PVAs) and PV Provisions
Session Chair(s)
Yvonne Ditoro, BSN, MBA, RN
Pharmacovigilance Operations Consultant
Yvonne Ditoro and Associates LLC, United States
- Various relationships requiring a PVA (also known as Safety Data Exchange Agreement) or PV provisions and the types of contracts
- Development of PVAs across clinical study programs and post-marketing, including regulatory requirements, updating, quality oversight, operational aspects, and best practices
- Exercise: Who is the functional owner of each agreement?