HP&M’s Jeff Shapiro to Speak at Harvard Law/Petrie-Flom Center Annual Conference on FDA in the 21st Century

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is is holding its annual conference on Friday and Saturday, May 3-4, 2013, at Harvard Law School in Cambridge, Massachusetts.  This year, the conference will focus on FDA and is titled “The Food and Drug Administration in the 21st Century.”  The conference boasts an impressive cast of speakers, with a keynote address from Deborah Autor, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy.

Conference topics include:

• Major Issues in Device Regulation
• Major Issues in Drug Regulation
• Balancing Access and Uncertainty
• The FDA in a Changing World
• Preserving Public Trust and Demanding Accountability
• Protecting the Public Within Constitutional Limits
• Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars

Hyman, Phelps & McNamara, P.C.’s Jeffrey K. Shapiro will be speaking about his paper, “Substantial Equivalence Review of Medical Devices” during the conference session on Major Issues in Device Regulation. The paper argues that the 510(k) program has proven its worth as a premarket pathway for medium risk devices, and has little-recognized strengths, including a proven ability to successfully balance patient safety with fostering innovation.

Attendance at the conference is free and open to the public; however, registration is required and space is limited.  A copy of the conference agenda is available here.  Additional information on registration is available here.  Any questions about the conference can be sent to petrie-flom@law.harvard.edu or by calling 617.496.4662.