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Manhattan Institute's Project FDA
Wednesday, May 15, 2013
8:30 AM - 2:00 PM
University Club | One West 54th St. at 5th Ave. | New York City, NY
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Issues and Case Studies in Clinical Trial Data Sharing – What Have We Learned?
Co-sponsored by the Multi-Regional Clinical Trial Center at Harvard University, and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School
Friday, May 17, 2013 (All day)
Wasserstein Hall, Milstein East (2nd Floor), Harvard Law School
1585 Massachusetts Avenue, Cambridge, MA
May 17, 2013 (7:30AM – 5PM)
Click to Register for this Event
Objectives:
- To discuss opportunities for and implications of emerging clinical trial data disclosure standards
- To review evidence from recent case studies in clinical trial data disclosure, especially related to disclosure of participant-level data
- To review the rationale behind disclosure requirements of patient-level data and discuss whether the case studies demonstrate the goals have been met
- To identify potential areas of collaboration among stakeholder groups, such as the formation of working groups to provide recommendations or standards in this area
- To review variance in regulatory approaches and areas for possible harmonization
- To identify other key areas of learning that may inform policy in this important area moving forward
- To use conference findings as basis of a publication in a peer-reviewed journal that captures the case studies, provides insights into these issues and offers recommendations for moving forward
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The O'Neill Institute for National and Global Health Law at Georgetown University is pleased to announce that it is accepting applications for its
Summer Program on Global Health Law and Governance: Non-Communicable Diseases and the Law.
The Summer Program will take place on June 17-21, 2012 at Georgetown Law in Washington DC. The program is open to all (lawyers and non-lawyers), and will bring together leading practitioners, policymakers, advocates, and academics in global health to explore the role and implications of law in the global response to Non-Communicable Diseases (NCDs). Interactive lectures, panels, and case studies will examine legal powers, duties, and constraints relevant to NCDs.
More detailed information about the Summer Program, including the application and logistical information, is available on this page: http://www.law.georgetown.edu/oneillinstitute/summerprogram/.
Any additional questions can be directed to oneillsummer@law.georgetown.edu.