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Life Science Compliance Update
Sailing with a New Safe Harbor in Sight: The EU-U.S. Privacy Shield
Beginning August 1, 2016, the United States Department of Commerce began accepting self-certifications to the EU-U.S. Privacy…
Managing Medical Inquiries in an Era of Data Analytics
Although compliance professionals tend to view Corporate Integrity Agreements (“CIAs”) as setting the basic compliance standards,…
Maintaining Independence & Objectivity – OIG Releases New IRO…
The Health and Human Services Office of Inspector General has released new guidance on an important topic, Independent Review…
Feeling Needy: The Why, What and How of Needs Assessments
Given trade association guidance and recent government involvement in life sciences transactions, this article emphasizes the…
Old Weapons with A New Purpose – Using Antitrust Laws to Control Drug…
U.S. Antitrust laws traditionally have been used to address, manage, and deter companies from engaging in anti- competitive…
Omnicare’s Unwanted Spotlight Produces Mixed Results
Omnicare has been in the news for two separate cases recently, one involving a whistleblower suit, and another involving Abbott…
Has Integrity Become a Commodity? – Warning Signs of Bad Behavior for…
This article takes a fresh look at trends in changing norms of ethical behavior by senior management and the challenge for…
Medical Affairs and Marketing: The Evolving Role of the Compliance Officer
Historically, medical affairs and marketing have directed both the generation and dissemination of information about their…
The Seventeenth Annual PCC: Day 2 Highlights
This article is a continuation of the previous article that discussed the first day of the 17th Annual Pharmaceutical and Medical…
The Seventeenth Annual PCC: Day 1 Highlights
The Annual Pharmaceutical and Medical Device Compliance Congress is an important opportunity for industry compliance professionals…