- Hear about policies affecting rare diseases in this evolutionary time: the opportunities, challenges and possible solutions
- Discuss the legislation that, by the time of the meeting, Congress is likely to have enacted, including special provisions applicable to orphan products
- Learn some of the administrative initiatives that FDA is considering that will affect product development and government reviews
- Learn strategies on how you can become a more effective advocate
Featured Speakers Include
Keynote:
- Stephen P. Spielberg, MD, PhD: Deputy Commissioner, Medical Products and Tobacco, Office of the Commissioner, FDA
Plenary:
- Cole Werble, MA: Founding Member, Prevision Policy, LLC
- David P. Meeker, MD: President and Chief Executive Officer, Genzyme
- Charles A. Mohan, Jr.: CEO/Executive Director, The United Mitochondrial Disease Foundation