- 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 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.