WILMINGTON, Del., March 5, 2010 /Business Wire/ -- Three pharmaceutical executives with extensive experience in dealing with the FDA’s Risk Evaluation and Mitigation Strategy (REMS) will share their thoughts and practices at an open industry webinar at 12 noon EST on Wednesday, March 10, sponsored by ParagonRx.
An open industry webinar at 12 noon EST on Wednesday, February 10, entitled " Beginning with the End in Mind: Managing the Lifecycle of REMS Implementation". It is the third in a series of monthly "Wednesday FoREMS" webinars sponsored by ParagonRx, an inVentiv Health company (Nasdaq: VTIV) and a leading consulting company specializing in pharmaceutical risk management and optimizing medication.
SOMERSET, N.J., Jan. 5, 2010 (GLOBE NEWSWIRE) -- inVentiv Health, Inc. (Nasdaq:VTIV), a leading provider of commercialization services to the global healthcare industries, today announced it has acquired ParagonRx, a leading consulting company specializing in pharmaceutical risk management and optimizing medication use. The addition of ParagonRx will position inVentiv as the leading provider of comprehensive, fully-integrated REMS (Risk Evaluation & Mitigation Strategy) and risk management solutions, ranging from strategic consulting and program design to implementation coordination, project tracking and assessment. The acquisition was completed on December 31, 2009.
Wilmington, DE, October 09, 2009 --(PR.com)-- Advisory to Medical Editors & Writers: Recently, the FDA issued a very important draft guidance for pharmaceutical and biotechnology companies for formatting, assessing and modifying Risk Evaluation Mitigation Strategies (REMS) to ensure the safe use of pharmaceutical products. Experts are now reviewing and interpreting this draft FDA guidance in a series of blogs.
WILMINGTON, Del., Oct. 1 /PRNewswire/ -- Yesterday, the FDA issued very important draft guidance for pharmaceutical and biotechnology companies for formatting, assessing and modifying Risk Evaluation & Mitigation Strategies (REMS) to ensure the safe use of pharmaceutical products.
WILMINGTON, Del., Sept. 30 /PRNewswire/ -- ParagonRx, a Delaware-based company specializing in pharmaceutical risk management and optimal medication use, has named Ellen M. Derrico as its chief marketing executive in a move to expand the company's market development.
WILMINGTON, Del., Sept. 14 /PRNewswire/ -- The airline and pharmaceutical industries both provide products and services that benefit mankind but which also can be dangerous if the risks are not properly calculated and dramatically lessened - but can drug manufacturers really learn from the experience of people who make and fly airplanes?
WILMINGTON, Del., Aug. 25 /PRNewswire/ -- While many pharmaceutical and biologics companies are getting accustomed to FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs for many new and old drugs, most are not adequately preparing for the equally mandatory program evaluations beginning just 1-1/2 years after each REMS is put into effect.
WILMINGTON, Del., Aug. 11 /PRNewswire/ -- ParagonRx, a healthcare consulting leader in risk management and the appropriate use of drugs, is sponsoring a free Webinar-on-Demand created by the Drug Safety Executive Council which discusses risk management as a role of chief safety officers in healthcare companies.
WILMINGTON, Del., July 15 /PRNewswire/ -- ParagonRx, a healthcare consulting leader in risk management and the appropriate use of drugs, has filed its interim analysis of a study that shows how its proprietary approach to risk management can help manufacturers of opioid drugs meet FDA standards for risk evaluation and mitigation strategy (REMS.) ParagonRx had presented abbreviated study results to the FDA during public hearings earlier this year.
WILMINGTON, Del., July 13 /PRNewswire/ -- ParagonRx, a Delaware-based company which specializes in programs for the appropriate use of medications, has launched a new website - www.paragonrx.com - that includes a "REMS Hub" for pharmaceutical and biotech companies needing information and assistance in complying with new FDA requirements to ensure the medical benefits of a drug outweigh its risks and dangerous side effects.
WASHINGTON, May 28 /PRNewswire-USNewswire/ -- Part of the answer in ensuring safe patient use of opioid medications lies in first identifying the ways the process of prescribing and dispensing medications may fail to protect patients from the risks of those products, and this can best be accomplished by conducting a failure mode and effects analysis or FMEA, Jeffrey Fetterman, a specialist in designing systems for preventing medication errors, told a public meeting held in Washington today by the Food & Drug Administration.