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Session 7: Generating Real World Evidence (RWE) Fit for Regulatory Decisions: Learning from Safety
Session Chair(s)
Annette Stemhagen, DrPH, PhD, FISPE
Chief Science Officer
UBC, United States
Robert Reynolds, DrSc, MSc, FISPE
Vice President, Epidemiology, Worldwide Regulatory and Safety
Pfizer Inc, United States
Tools and expertise exist in pharmacovigilance to ensure that real world data meet the necessary quality standards for regulatory decisions. Studies are already being designed in accordance with current best practices to reduce bias and produce valid results. This session builds on the long standing use of RWE in PV to provide lessons, case studies, and guidances relevant to the goal of developing a broader framework for integrating RWE in regulatory decision making.
Learning Objective : Upon completion of this session, the participant should be able to:- Describe the common uses of RWE in pharmacovigilance and risk management
- Summarize the key scientific criteria for evaluating the quality of RWE for regulatory decisions
- Identify circumstances where RWE may appropriately supplement drug development
Speaker(s)
When and How can RWD Analyses Support Regulator Decision-Making
Sebastian Schneeweiss, DrSc, MD
Harvard Medical School and Brigham and Women's Hospital, United States
Professor, Medicine and Epidemiology; Chief of the Div of Pharmacoepidemiology
RWE for Drug Development and Regulatory Approvals
Cathy W Critchlow, PhD, MSc
Amgen, Inc, United States
Vice President, R&D Data Strategy
21st Century Cures and the evaluation of RWE at FDA
David Martin, MD, MPH
Novartis, United States
Vice President, Head, PCO Center of Excellence
Panelists
Cathy W Critchlow, PhD, MSc
Amgen, Inc, United States
Vice President, R&D Data Strategy
Panelists
Andrew Robertson, JD, PhD
Takeda, United States
Vice President, Head of Global Regulatory Policy and Innovation
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