is being presented by Jamie L. Kendall, Esq., Sr. Director, with Compliance Implementation Services, LLC and airs on Wednesday, September 7th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Corporate Integrity Agreements (CIAs) serve as intelligible “tea leaves” as the government’s focus on commercial-related activities continues to lead to medical affairs activity scrutiny. Who would have thought that CIAs executed over the past several years related to commercial activities should be construed as putting the pharmaceutical industry on notice that the government would be shifting its focus to include medical and scientific affairs activities? As the rise of recent off-label investigations and subsequent CIAs continue to become public, it is clear from CIA provisions that the government will be heavily scrutinizing medical affairs departmental activities.
Recent trends within the industry provide for a period of unprecedented change. The increase in high-profile government investigations leaves little room for mistakes within the medical and scientific affairs arena, as well as within the pharmaceutical industry in general. As CIA provisions serve as “tea leaves,” all companies within the industry are on notice that proper proactive compliance initiatives across all business units are essential.
This presentation provides attendees with an in-depth look at the government’s enforcement focus on medical affairs activities through settlements and CIA provisions, offers a commercial and medical affairs activity overlap discussion, best practices, and a discussion around off-label marketing and the evolving role of the medical science liaison.
