Covance Experts to Present Key Insights on Risk Management at Bio/Pharmaceutical Drug Safety Forum
March 31 2009 - 2:00PM
PR Newswire (US)
- 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. About
Covance 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 http://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.
DATASOURCE: Covance, Inc. CONTACT: Media Relations,
+1-609-419-2466; or Investor Relations, +1-609-452-4807 Web Site:
http://www.covance.com/
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