RECORDED SEMINARS
Recorded Seminar
FDA REMS & Post marketing Surveillance Studies
(New laws and Recent Changes t oFDA Approach and the design and conduct of post-marketing surveillance studies)
timelapse 4 Hrs with 10-15 mins of Q and A
Note:
Recorded Seminar can be played unlimited times
Along with recorded seminar, copy of presentation slides will be shared
Speaker/Presenter
Short Abstract
This workshop will provide you with the knowledge to understand the new FDA requirements for Risk Evaluation and Management Strategies (REMS) and the tools to design these programs and execute post-marketing surveillance studies to evaluate the effectiveness of these programs.
Program Agenda
This workshop will cover the following areas:
- How to work with the FDA to get REMS approval – when and what to file.
- Design and validation of REMS programs – pre and post-marketing.
- Design, approval, conduct and analysis of post-marketing studies.
- Case studies of approved REMS programs and post-marketing studies.
Registration Information
- Registration Fee : USD $299
- For assistance on registration, please send an email to
marketing@biopractice.com or
Please call: Ph - 1-646-216-8860