Tuesday, October 9
11:30 a.m. – 12:30 p.m.
Hosted by Jones Day
Our panel will include representatives from the National Institutes of Health, the Pancreatic Cancer Action Network, Sanofi, the U.S. Food and Drug Administration, and Jones Day. The panel will address various legal, regulatory, policy, and technical issues associated with the goal of achieving greater diversity in clinical trial participation, particularly with regard to women.
The substantive topics to be addressed will include an analysis of: i) relevant provisions of the 21st Century Cures Act; and ii) regulatory guidance documents issued by federal agencies addressing the inclusion of women, including pregnant and lactating women, in clinical trials. In addition, the panel will address regulatory and technical advances allowing for the development of novel clinical trial protocols and remote participation in clinical trials, along with practical implementation issues. Finally, the panel will address evolving NIH and FDA initiatives in the area of women’s health that are intended to increase diversity among clinical trial participants.
- Dr. Victoria Manax, Chief Medical Officer, Pancreatic Cancer Action Network
- Dr. Samia Noursi, Associate Director – Science Policy, Planning and AnalysisOffice of Research on Women’s Health (ORWH)
- Maureen Bennett, Partner, Jones Day
This program has been approved for 1.00 hour of general credit by the Pennsylvania CLE Board. This program has also been approved for 1.00 hour of general credit by the State Bar of California and 1.00 hour of areas of professional practice credit (including transitional credit) by the New York State CLE Board. Jones Day is a Pennsylvania CLE Board accredited provider, a State Bar of California MCLE approved provider, as well as an accredited provider in New York. Application for CLE credit in other states will be made as needed.