backProgram Speakers
Dan Donovan, Beverly Lorell, MD, Seth H. Lundy, Christina Markus
Description
Join us for a discussion of continuing transparency trends regarding clinical trial data disclosure, as well as the disclosure of Medicare payments to physicians for uses of pharmaceutical and medical device products. We will examine the trends driven by both industry and federal agencies for increasing public access to clinical trial data, including results and adverse events. This program will also explore the implications of the plan that CMS recently announced for regular public disclosure of Medicare payments to physicians. Learn about (1) key proposed changes in disclosure of clinical trial data on ClinicalTrials.gov in the recent proposed rule; (2) the new Institute of Medicine (IOM) recommendations for sharing of de-identified “per person” clinical trial data sets; and (3) how leaders in pharmaceutical and medical device industry are enabling rational access to “per person” data. We will also address the CMS plan to annually disclose all Medicare payments to physicians, and look at the drivers for expanded data disclosures under the current Obama administration and Congress. Finally, we will analyze the potential implications of expanded clinical data disclosures on federal enforcement actions.
You may register for the program here.
If you have questions that are not addressed during the program, please contact one of the speakers and they will be happy to answer them.
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Contact
Kristina Sooy
Professional Development Coordinator
King & Spalding LLP
1180 Peachtree Street NE
Atlanta, GA 30309
+1 404 572 3042 Direct
ksooy@kslaw.com