Howard Dorfman to speak at CBI's 10th annual 'Guidelines for Disseminating Off-Label Information' conference in October
Ropes & Gray is pleased to support CBI's 10th annual 'Guidelines for Disseminating Off-Label Information' conference. The two-day event will address best-practices issues in communicating medical information in a changing legal and regulatory landscape.
Conference highlights include:
- Implementing internal processes that ensure compliant dissemination of information and literature at medical meetings;
- Leveraging scientific information through published documents and communications with HCPs and P&T committees;
- Discussion of the submission process of off-label information to select guidelines and compendia; and
- Determining the immediate practical applications of the FDA Draft Guidance for Industry on "Good Reprint Practices."
Ropes & Gray counsel Howard Dorfman will discuss the immediate practical applications of the FDA Guidance, including the determination of how to identify and provide counsel to the appropriate in-house functions; how to evaluate effective methods to integrate the role of the legal and compliance groups in developing company guidance; and the evaluation of the company's risk profile in the broadest context. For program, faculty and registration, please click here.