American Conference Institute’s 9th Advanced Summit on

Off-Label Communications

The Definitive Legal and Regulatory Forum on the Evolving Off-Label Landscape

Wednesday, June 26 to Thursday, June 27, 2013
ONE UN New York Hotel, New York, NY

Blockbuster Fines Await Those Who Run Afoul of the FDA Off-Label Promotion Ban

The numbers are staggering: billions of dollars in fines have been levied against drug and medical device manufacturers during an unprecedented enforcement effort. The government has shown no sign of letting up in its prosecution campaign, showing a willingness to utilize a broad array of legal theories to attack what it considers to be impermissible promotion of products for unapproved uses. What’s more, case law from high profile prosecutions like Caronia and Harkonen complicate the environment for leaders at manufacturers, making a murky set of rules and laws even more inscrutable. Compliance managers, marketing executives, and counsel need guidance on evolving case law, new regulatory developments, and shifting enforcement priorities.

Navigate the Labyrinthine Rules Governing Off-Label Communications

In response to these changing regulations and interpretations, American Conference Institute’s 9th Advanced Summit on Off-Label Communications brings together a top faculty of federal prosecutors, in-house experts, and experienced practitioners to help attendees:

·         Master the First Amendment defense being pioneered in Caronia

·         Calibrate policies and procedures to remain in bounds of the latest rules on off-label communications

·         Benchmark best practices against those of major drug and medical device manufacturers

·         Improve your ability to address novel trends in litigation, including the rise of class action lawsuits against manufacturers

·         Establishing controls and standards for information dissemination via social media in the absence of clear guidance

NEW THIS YEAR: In response to market concerns, ACI is proud to announce the inclusion of a pre-conference workshop on Conforming to Stringent cGMP Standards: Utilizing Best Practices, Procedures, and Protocols to Avoid FDA Sanction. At this workshop, easily attended the morning before the commencement of the general session, attendees will learn best practices to devise protocols to comply with cGMP regulations and retain the flexibility to adapt your manufacturing operations to inevitable changes in cGMP standards.

Ensure that you remain fully equipped to manage off-label compliance concerns. Register by calling 888-224-2480, by fax at 877-927-1563, or online at www.americanconference.com/offlabel.