Navigation Links
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."

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.


'/>"/>
SOURCE Covance, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Covance to Present at the Barclays Capital Global Healthcare Conference
2. Covance Elects Bradley T. Sheares to Companys Board of Directors
3. Covance to Present at the 2009 UBS Global Healthcare Services Conference
4. Covance Opens Three New Offices in Ukraine, Slovakia, and Israel
5. Covance Reports Fourth Quarter and Full-Year 2008 Results
6. Covance to Present at the 27th Annual J.P. Morgan Healthcare Conference
7. Covance Inc. Invites You to Join the Webcast of Its Fourth Quarter 2008 Financial Results Conference Call
8. Covance Inc. Invites You to Join the Webcast of Its 2009 Guidance Conference Call
9. Covance to Present at the Credit Suisse 2008 Healthcare Conference
10. Covance and Lilly Enter Into a Strategic R&D Collaboration
11. Covance Recognized for Outstanding Performance by Merck & Co., Inc.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... (PRWEB) , ... February 11, 2016 , ... Image ... business to a new market, and it’s the buildings of Nashville that will benefit. ... when I needed to relocate to Nashville, there was no question that I would ...
(Date:2/11/2016)... (PRWEB) , ... February 11, 2016 , ... ... advocates will discuss how to improve care by making data on heart procedures ... disease. The Summit on Transparency and Public Reporting of Pediatric and Congenital Heart ...
(Date:2/11/2016)... Plantation, Fla. (PRWEB) , ... February 11, 2016 ... ... CareTRAK™, an unparalleled clinical decision support technology, with highly adaptable algorithms, has ... cases. When a patient has signs and symptoms consistent with Zikas and a ...
(Date:2/11/2016)... ... February 11, 2016 , ... Life is known for ... men, 60 and older, who gather once a year to play softball to raise ... for the game, the more than 50 players who competed in this year’s softball ...
(Date:2/11/2016)... , ... February 11, 2016 , ... ... practice Village Family Practice , will be presenting at the 2016 HIMSS ... Las Vegas, Nev. , During his session, “ Coding for Care: Using ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... 2016  MiMedx Group, Inc. (NASDAQ: MDXG ), ... and other birth tissues, human skin and bone, and ... advanced products and therapies, announced today that it will ... Conference in New York , NY.  ... J. Senken , Chief Financial Officer and Chris ...
(Date:2/11/2016)... 11, 2016  AfterPill.com is reporting that this week,s ... for all women who are at risk of unintended ... year and raises the risks of unprotected sex in ... According to the Guttmacher Institute, there are 43 ... child-bearing age, who have sex without the intention of ...
(Date:2/11/2016)... Wearable posture tracker, ALEX , has taken Kickstarter by storm, crowdfunding over $60,000 – or 120% ... ALEX is said to be delivered to backers starting May of this year. ... ... ... Created by NAMU, a team of biomedical engineers out ...
Breaking Medicine Technology: