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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
Deputy Division Director, DABRA, OBPV, 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)
David Moeny, MPH, RPH
Deputy Director, Office of Pharmacovigilance and Epidemiology, OSE/CDER, FDA, United States
Introduction to the International Council on Harmonization and the M14 Guideline
Motiur Rahman, PHD, MPHARM, MS
Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States
Real-World Evidence: Regulatory Considerations and PDUFA VII Commitments
Catherine Cohet, PHD
Senior Pharmacoepidemiologist, Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
Update on Guidance from EMA on RWE Generation
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