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THE US GRANT, a Luxury Collection Hotel, San Diego

Nov 10, 2022 7:00 AM - Nov 11, 2022 12:30 PM

326 Broadway, San Diego, CA 92101

Real-World Evidence Conference

Translating Insights into Real-World Value

Session 2: Regulatory Updates

Session Chair(s)

Marni  Hall, PhD, MPH

Marni Hall, PhD, MPH

Vice President and General Manager, Global Regulatory Science and Strategy

IQVIA, United States

Yun  Lu, PhD, MS

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


David  Moeny, MPH, RPh

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

Motiur  Rahman, PhD, MPharm, MS

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

Catherine  Cohet, PhD

Update on Guidance from EMA on RWE Generation

Catherine Cohet, PhD

European Medicines Agency, Netherlands

Senior Pharmacoepidemiologist, Data Analytics and Methods Task Force

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