Quantcast
Last updated on April 19, 2014 at 1:20 EDT

Latest ParagonRx Stories

2013-08-19 08:29:09

Dr. Stephen W. Sun to Support Clients with Regulatory and Strategic Insights on the Optimal and Safe Use of New Drugs and Devices BURLINGTON, Mass., Aug. 19, 2013 /PRNewswire/ -- ParagonRx, an inVentiv Health company offering product safety risk management and healthcare systems consulting to pharmaceutical and medical device companies, announced today the appointment of Stephen W. Sun, MD, MPH, as Chief Medical Officer advising clients on regulatory and safety issues. Dr. Sun,...

2010-01-12 06:45:00

WILMINGTON, Del., Jan. 12 /PRNewswire/ -- More than 80 Risk Evaluation and Mitigation Strategy (REMS) plans have been approved by the Food & Drug Administration since their inception in March 2008. Now, pharmaceutical companies must formally assess and report on how well these plans have actually been working in reducing drug risks, a mandated step in the REMS process. This will be the topic of an open industry webinar at 12 noon EST on Wednesday, January 13 entitled "Cracking the Code...

2009-12-03 13:00:00

WILMINGTON, Del., Dec. 3 /PRNewswire/ -- ParagonRx, a Delaware-based company specializing in pharmaceutical risk management and optimal medication use, will host a free webinar on Wednesday, Dec. 9, on the FDA's draft guidance on REMS - Risk Evaluation Mitigation Strategy - programs and its implications for REMS lifecycle management. Dr. Gary Slatko, chief medical officer of ParagonRx and an expert on REMS and risk management programs, will lead the one-hour program beginning at 11 a.m....

2009-11-11 14:00:00

WILMINGTON, Del., Nov. 11 /PRNewswire/ -- A drug safety expert says the Food & Drug Administration (FDA) has shifted from its traditional role of managing pharmaceutical drug safety to trying to preempt drug risks through its REMS - Risk Evaluation Mitigation Strategy - programs, which he characterizes as having reached their "terrible twos" stage of development. Speaking at a Cambridge Healthtech Institute conference last week, Dr. Gary Slatko, chief medical officer of ParagonRx, said...

2009-09-30 09:00:00

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. Prior to joining ParagonRx, Derrico served as interim vice president of business development, sales and marketing for P-Wave and as executive advisor and consultant to Acurian and NanoScan Imaging. She is founder, chair and...

2009-09-14 13:00:00

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? "Yes" is the conclusion of two experts who conducted a recent webinar on the topic - Captain Ben Berman, senior research associate at San Jose State...

2009-08-25 12:00:00

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. That warning has been issued by risk management expert Jeffrey Fetterman, CEO of ParagonRx, a Delaware-based company specializing in...

2009-08-11 14:00:00

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. The webinar can be accessed at ParagonRx's website, www.paragonrx.com/experience/webinars/. "ParagonRx has historically been instrumental in the development of risk management...

2009-07-15 14:30:00

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. The interim analysis can be accessed at...

2009-07-13 13:30:00

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. "REMS, or Risk Evaluation and Mitigation Strategy, requires a whole...