
ICPE conference
RWE Hot Topic Webinar Series: Part 1 Real-world evidence to support regulatory decision making: New or expanded medical product indications
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Title: RWE Hot Topic Webinar Series: Part 1 Real-world evidence to support regulatory decision making: New or expanded medical product indications
Speaker: Jessica Franklin, Optum Epidemiology, and Brigham and Women's Hospital, Harvard Medical School
Moderators: Mehmet Burcu, Merck & Co., Inc. (Kenilworth, NJ)
Darren Toh, Harvard Medical School and Harvard Pilgrim Health Care Institute
Date: June 10, 2021
Time: 12:00-1:00 pm EDT
Description: ISPE RWE Taskforce manuscript development subteam announces its 3-part webinar series focusing on recently completed RWE manuscripts to promote knowledge exchange of scientific methods and standards and education, related to the development, implementation, and interpretation of RWE.
The 3 topics will be in the following areas:
1. RWE to support regulatory decisions of new or expanded indications
2. Pragmatic trial extensions using RWE
3. Methods to mitigate biases in the post-COVID19 era