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14th Annual Forum on Off-Label Guidelines

Regulatory Guidance • Field Force Oversight • Promotional Review

October 11-12, 2012
  • Philadelphia, Pennsylvania

Available for $298.00

Join us in our 14th year, as we continue to provide pharmaceutical, biotech and medical device manufacturers with the most timely and relevant updates related to off-label compliance and information.

As legal and regulation challenges arise from the release of the recent FDA Guidance, the industry must continue to revaluate and update their internal SOPs to ensure all medical and promotional information complies with current off-label regulations. This interactive forum provides a platform for industry peers to review and discuss best practices regarding compliance and legal oversight as well as an opportunity to discuss industry benchmarks, activities and practical guidelines for off- label information. 

  • Discuss implications of the FDA Guidance released in December of 2011
  • Understand the current regulatory environment for off-label information
  • Learn from industry experts how companies are monitoring interactions between field force teams and prescribers
  • Define what constitutes as solicited vs. unsolicited information
  • Review influential court cases as well as recent OPDP warning letters regarding off-label allegations

FEATURING: Federal Prosecutors’ Discussion: Recent Trends in State and Federal Enforcement — Evaluate Recent Complaints, Investigations and Settlements with Federal Prosecutors

Jacqueline C. Romero
Assistant U.S. Attorney
U.S. Attorney’s Office for the Eastern District of Philadelphia

Ross Goldstein
Trial Attorney
U.S. Department of Justice Consumer Protection Unit

Paul Kaufman
Assistant U.S. Attorney, Chief, Civil Healthcare Fraud
U.S. Attorney’s Office E.D.N.Y 

Susan Winkler
Chief, Health Care Fraud Unit at US Attorney’s Office
U.S. Attorney’s Office for Boston, MA

 


 

Pharmacists:
Amedco is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Successful completion of this program qualifies for up to 12 contact hours.  Full attendance is required.  No partial contact hours will be awarded for partial attendance. 

 


 

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Independent Commercial Compliance™ (ICC) is a full service health care compliance agency with expertise in all compliance related matters in the pharmaceutical and medical device industries.