American Conference Institute’s 9th Advanced Summit on
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.
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Wed, Jun 26, 2013
Thu, Jun 27, 2013
ONE UN New York Hotel
New York, NY
Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.
ACI certifies that the activity has been approved for CLE credit by the New York State Continuing Legal Education Board in the amount of 10.5 hours. An additional 3.5 credit hours will apply to workshop participation.
ACI certifies that this activity has been approved for CLE credit by the State Bar of California in the amount of 8.75 hours. An additional 3.0 credit hours will apply to workshop participation.You are required to bring your state bar number to complete the appropriate state forms during the conference. CLE credits are processed in 4-8 weeks after a conference is held.
ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.Questions about CLE credits for your state? Visit our online CLE Help Center at www.americanconference.com/CLE