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Session 1: Setting the Stage, Global Regulatory Experience (and Data Quality Standards)
Session Chair(s)
Inger Mollerup, MS, MSc
Consultant, Inger Mollerup Regulatory Consulting, Denmark
Sources for Real World Data supporting RWE are multiple and include electronic medical records, medical charts, claims data, product and disease registries, and patient generated data/patient reported outcomes. In the regulatory environment, safety databases (e.g. FDA’s Sentinel System and PMDA’s MID-NET) are used to follow drug safety in the post marketing space, and examples of other regulatory use of RWD such as the supportive RWE to provide data on historical response rates drawn from chart are appearing. In this session we will hear about the approach for utilising RWE for regulatory purposes from the 3 major regions, EU, US and Japan, what requirements they have to ensure that the quality of the data can support regulatory decisions, and what their expectations are for future use of RWE.
Speaker(s)
Peter Mol, PharmD, PhD
CHMP member, NL, MEB, Netherlands
Use of Real World Data for Regulatory Purposes Pre- and Post-Approval, European Perspective and Experience
Yoshiaki Uyama, PhD, MS, RPh
Associate Executive Director, Regulatory Science Center, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Utilising Real World Data: PMDA’s Perspective and Experience Based on Japanese Databases (REMOTE via Zoom)
M. Khair ElZarrad, PhD, MPH
Vice President, Regulatory Policy, BridgeBio, United States
Incorporating Real World Evidence into Regulatory Decision Making: FDA Perspective, Guidance and Experience
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