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Session 2: Regulatory Updates
Session Chair(s)
Marni Hall, PhD, MPH
Vice President and General Manager, Global Regulatory Science and Strategy
IQVIA, United States
Yun Lu, PhD, MS
Mathematical Statistician, Office of Biostatistics and Pharmacovigilance, CBER
FDA, United States
During the past year, the US FDA has published many Real-World Data (RWD) and Real-World Evidence (RWE) related guidance documents and draft guidelines. This session will cover recently published FDA guidance documents, as well as emerging guidance documents from other regulatory bodies.
Learning Objective : - Recognize the role of Prescription Drug User Fee Act (PDUFA) in evolving RWE regulatory landscape
- Recognize the role of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in harmonizing existing RWD/RWE guidances across the globe
- Interpret and apply newly published guidance documents from US FDA and EMA RWE to regulated product development
Speaker(s)
Introduction to the International Council on Harmonization and the M14 Guideline
David Moeny, MPH, RPh
FDA, United States
Acting Deputy Director, Office of Pharmacovigilance and Epidemiology, OSE/CDER
Real-World Evidence: Regulatory Considerations and PDUFA VII Commitments
Motiur Rahman, PhD, MPharm, MS
FDA, United States
Senior Epidemiologist, Real World Evidence Analytics, OMP, CDER
Update on Guidance from EMA on RWE Generation
Catherine Cohet, PhD
European Medicines Agency, Netherlands
Senior Pharmacoepidemiologist, Data Analytics and Methods Task Force