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Enforcement Trends and Public Policy: Lessons Learned and Practices to Follow
Program Code:
338
Date:
Wednesday, June 26, 2013
Time:
10:15 AM to 11:45 AM
EST
CHAIR
:
Barry A. Berger,
JD,MBA (SCHSUP), Professor of Regulatory Affairs,
Temple University, United States
Barry Berger is Professor of Regulatory Affairs, at Temple University’s, School of Pharmacy, QA/RA Graduate Program. Prior, to his appointment to the full time faculty, Mr. Berger had served in senior positions with both multinational and startup pharmaceutical and biotech companies.
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SPEAKER
(S):
Adolfo R. Garcia, JD (SPKNON), Partner, Brown Rudnick, United States
Susan G. Winkler,
(SPKAGY), Assistant US Attorney,
US Attorney's Office, District of Massachusetts, United States
Susan is an Assistant U.S. Attorney in the Boston Office. She has been devoted to prosecuting health care fraud civilly and criminally for more than 16 years. Under her leadership, the Office recovered more than $10.8 billion in fines and damages, and handled groundbreaking national prosecutions.
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Description
In the context of recent compliance and enforcement trends, this forum will ask and answer such questions as: Should FDA and other government agencies place more of a priority on criminal enforcement? How has the Park doctrine and the Responsible Corporate Officer doctrine evolved, and is this good public policy? What is the significance of recent False Claims and Whistleblower lawsuits? What is the significance of the Foreign Corrupt Practices Act on our global industry? And, what can we learn from past government actions, and how should what we learn impact our future practices?