- 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."
Covance Periapproval Services offers a broad spectrum of post-marketing services, ranging from Phase IIIb/IV clinical studies to registries and observational studies, risk management, epidemiology, and product safety services. As a leader in the design and implementation of Risk Evaluation and Mitigation Strategies (REMS), Covance's periapproval services team offers unique tools and methodologies specifically designed to meet clients' post-approval goals.
Covance, with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies with annual revenues greater than $1.7 billion, global operations in more than 25 countries, and more than 9,600 employees worldwide. Information on Covance's products and services, recent press releases, and SEC filings can be obtained through its website at www.covance.com.
Statements contained in this press release, which are not historical facts, are forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All such forward-looking statements including the statements contained herein regarding anticipated trends in the Company's business are based largely on management's expectations and are subject to an qualified by risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, competitive factors, outsourcing trends in the pharmaceutical industry, levels of industry research and development spending, the Company's ability to continue to attract and retain qualified personnel, the fixed price nature of contracts or the loss of large contracts, and other factors described in the Company's filings with the Securities and Exchange Commission.
|SOURCE Covance, Inc.|
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