CBI Off-Label Guidelines: "Strategies for Safe Communication of HEOR Information"
Wyndham Philadelphia Historic District, 400 Arch Street, Philadelphia, PA 19106
Jennifer Romanski presented, "Strategies for Safe Communication of HEOR Information" at the CBI Off-Label Guidelines Meeting, 10:40 AM which occured on Tuesday, June 23, 2015.
Over the past few years, pharmaceutical and medical device companies have paid over 13 billion dollars to resolve U.S. Department of Justice cases involving allegations of fraudulent marketing practices. Therefore, it is crucial to understand where the government stands on these issues. Industry best practices regarding the following were covered:
- Medical affairs oversight
- Field-force compliance
- Promotional review
- Speaker program compliance
- Internal processes to minimize risk of off-label communications
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