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
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) Pragmatic trial extensions using RWE
2) Methods to mitigate biases in the post-COVID19 era
3) RWE to support regulatory decisions of new or expanded indications7.
Webinar Goal and Learning Objectives
1) Promote knowledge exchange of scientific methods and standards and education, related to the development,implementation, and interpretation of RWE
2) Disseminate information from recently completed ISPE RWE Task Force manuscripts with ISPE audience
3) Promote discussion on emerging hot topics in the area of RWE to support future research, development, and planning