Course Description

Patient registries are based on principles of observational research and offer remarkable flexibility in design and applications. They have demonstrated value in  both the biopharmaceutical and the medical device arenas. Patient registries are appealing to physician investigators, and can serve as a centerpiece or as an adjunct to a productEEs late-phase scientific and promotional strategy.

Although registries share some features with clinical development trials, they diverge in many important respects. Clin"l, risk management, and product marketing teams can collaborate successfully to develop and implement patient registry programs. All team members should have a clear understanding of the design elements, the operational issues, and the strengths and limitations of registries.

This web seminar will focus on the most critical issues in the design and conduct of patient registries for biopharmaceutical and medical device applications. It will also cover the questions most frequently raised by clinical, risk management, and product marketing teams engaged in the development and implementation of registries.

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Learning Objectives

• Discuss all the basic components of a successful registry program
• Examine when patient consent and IRB/Privacy Board approval is required
• Design benchmark reports that physicians will actually want to read
• Turn community physicians into comfortable, productive registry site investigators
• Choose study endpoints: Walking the tightrope between what is desirable and what is realistic

Who Should Attend

• Clinical Programs/Trials Professionals
• Clinical Research Professionals
• Clinical Affairs Professionals
• Medical Affairs Professionals
• Regulatory Affairs Professionals
• Project Managers
• Patient Registries Professionals
• Marke