CHAIR
:
SPEAKER
(S):
Mark Raza, Associate Chief Counsel, Office of the Chief Counsel, Food and Drug Administration
Cheryl Scarboro, Associate Director of the SEC Division of Enforcement, Securities and Exchange Commission
Walter Ricciardi, District Administrator of the SEC Boston Office, Securities and Exchange Commission
Joseph Braunreuther, General Counsel, Pharmaceuticals Group, Johnson & Johnson
Description
Leading panelists from the SEC, FDA and life sciences industry will be joined by Robert Ullmann, Nutter McClennen and Fish's Government Enforcement Defense practice chair. The program will focus on how not to run afoul of the SEC, the FDA and the Justice Department.
Objectives:
Inform attendees about the roles that the FDA, the SEC and the Justice Department play in law enforcement matters that affect biotechnology and other life sciences companies.
Describe key current law enforcement initiatives and priorities in the field of biotech and life sciences, such as the cooperation agreement between the SEC and the FDA, and what enforcement agencies are scrutinizing when it comes to financial arrangements with physicians, clinical trials and off-label sales.
Educate attendees about the affirmative steps companies can take to avoid running afoul of the FDA, the SEC and the Justice Department, and what types of conduct should be avoided.