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Covance Experts to Present Key Insights on Risk Management at Bio/Pharmaceutical Drug Safety Forum
Date:3/31/2009

- Covance's periapproval services experts to discuss REMS consulting, design and implementation -

PRINCETON, N.J., March 31 /PRNewswire-FirstCall/ -- Covance Inc. (NYSE: CVD) experts will present key insights on risk management and risk evaluation and mitigation strategies (REMS) at the 5th Annual CBI Bio/Pharmaceutical Drug Safety Forum from March 30-31, 2009 in Washington, D.C.

Glynis Neagle, M.D., Covance's vice president of medical affairs for periapproval services will chair the two-day event, designed to examine safety and risk initiatives and provide in-depth coverage on REMS implementation and follow-up.

On Monday, March 30, Edgar H. Adams, ScD, Covance's executive director of epidemiology will present "Risk Minimization Strategies for REMS Development." This presentation will discuss how the Food and Drug Administration Amendments Act (FDAAA) of 2007 has impacted drug development by mandating REMS and enforcing penalties of up to $10 million dollars to companies who fail to adhere.

Focusing on new drug development, Dr. Adams will also discuss the importance of thoroughly understanding a new drug's potential risk prior to approval to avoid delay due to mandated REMS. Full understanding of risk enables the development of a REMS that balances benefit, risk and burden so that patient access is maximized while risk and undue burden are minimized, according to Dr. Adams.

"Pharmaceutical and biotechnology companies are facing a variety of potential compliance challenges as a result of FDAAA," said Dr. Neagle. "With a focus on REMS across drug development, new risk management solutions need to be designed to help sponsors avoid costly delays that may result from the FDA's increased scrutiny of drugs not currently governed by safety restrictions."


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SOURCE Covance, Inc.
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