Past Events
Speaker: Aaron Seth Kesselheim, MD, JD, MPH, Professor of Medicine, Brigham and Women’s Hospital and Harvard Medical School
Time: 1:00 p.m. - 2:00 p.m. EDT
Location: Zoom Webinar
Please join us for this Virtual Grand Rounds featuring Dr. Aaron Kesselheim as he reviews the basic legal standard for FDA drug approval and how it has evolved over the years.
He will then review the special accelerated approval pathway created by FDA in 1992, its outcomes, and its limitations. Finally, he will apply these principles to the review and approval of aducanumab and discuss policy solutions intended to promote safe and effective application of the accelerated approval pathway.
Registration:
This program will only be offered online. 1.0 hour Indiana CLE (Distance Education) credit will be available but you must register for the Zoom Webinar using the link below. Following registration, you will receive an email with a link to join the Webinar.
Ensure you are joining the webinar from the Zoom application (desktop or mobile) to enable participation in the polling throughout the webinar for CLE credit. Please note joining the webinar from a web browser is not compatible and doing so will result in not receiving CLE credit.
E-mail certificates will be provided certifying attendance for those wishing to apply for CLE credit outside of Indiana.
About the Speaker:
Dr. Kesselheim is a professor of med.jpg)
icine at Brigham and Women’s Hospital and Harvard Medical School and the Director of the Program On Regulation, Therapeutics, And Law (PORTAL), one of the largest independent research centers in the US focused on the pharmaceutical market.
