March 21 – 22, 2011 in Philadelphia, PA ~

The purpose of the REMS is to ensure the benefit of the drug outweighs the risk. Penalties for failure to adhere start at $250,000 and could potentially reach $10 million. In the absence of an official guidance from the FDA on REMS, the responsibility lies with the pharmaceutical company to develop, implement and manage their REMS.

Building off of a successful two year history, CBI’s third annual forum gives a comprehensive look at REMS development, implementation and assessment. REMS case studies present a detailed view of the experience within the industry and panel discussions cover top issues surrounding this crucial topic.

Topics being researched include:

• Benefit/risk assessments
• REMS preparation
• Failure Mode and Effects Analysis (FEMA)
• Impact of REMS throughout the organization – Clinical, safety, IT, marketing
• Effective REMS communication tools

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