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Covance Experts to Present Key Insights on Risk Management at Bio/Pharmaceutical Drug Safety Forum
- On 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), About 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 |