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Video

Plenary Session

Session: Plenary Session

Patient Involvement in the Development and Safe Use of Medicines

Saturday, August 26, 2023
10:00 AM – 11:30 AM ADT
Location: Ballroom
Publication Number:
Regional authorities worldwide have called for greater patient involvement in the development and safe use of ‎medicines, including:‎
‎--IMI-Prefer (EU) for obtaining patient preferences in medical product decision making
‎--US FDA Patient-Focused Drug Development (PDUFA VII Commitment) for capturing meaningful incorporation of ‎patient voice into drug development and evaluation
‎--EMA Good Pharmacovigilance Practice (GVP Module XVI, Rev 3) for patient engagement concerning additional risk ‎minimization measures, including selection of tools and effectiveness indicators.‎

The 2022 Report from the Working Group XI Council for International Organizations of Medical Sciences (CIOMS) ‎advanced the global importance of systematically involving patients throughout a medicine's life – from its early ‎development through the regulatory process to ongoing monitoring and safe use in everyday healthcare."‎

ISPE member feedback indicates interest in simple, pragmatic approaches for engaging patients in routine drug safety ‎research and emerging regulatory and scientific guidance.