Video / Podcasts
Presentation to FDA about the Utility of Failure Modes and Effects Analysis for the Long-Acting Opioid REMS
Jeff Fetterman, President of ParagonRx, recaps his presentation to the FDA about the science-based approach ParagonRx uses for risk management that can help manufacturers of opioid drugs meet FDA standards for risk evaluation and mitigation strategy (REMS). ParagonRx had presented interim analysis results to the FDA during public hearings in June, 2009.
RxFMEA® in REMS Development
ParagonRx has developed a proprietary approach to risk management using an adaptation of failure modes and effect analysis called RxFMEA®. Please watch our Clinical Services Manager Marc DeLuca discuss the development of the RxFMEA and how it could be helpful to you as you develop your REMS or appropriate use program.
Process of Care®
Process of Care® is a turnkey process to optimize medication use while minimizing risks. Kim Bullano, PharmD, our expert in appropriate use and ethnographic research, discusses the components that include a CareMap™ that synthesizes identified clinical practices, processes, and tools used at the point of care.
Science-Based Approach to Opioid REMS
The shared-system REMS for the long acting opioids will be a landmark event of interest to the entire pharmaceutical industry. A program that includes over 20 manufacturers, millions of prescriptions, and over 100,000 prescribers will be complex. Listen to Jeff Fetterman, President of ParagonRx and an expert in the field of pharmaceutical risk management, discuss how a science-based method such as failure modes and effects analysis could support the process.
Risk Mitigation and Its Impact on Pharma Marketing
Monday, September 28, 2009
From Pharma Marketing Talk, an online talk show hosted by Pharma Marketing News.
A conversation with Jeff Fetterman, President and CEO of ParagonRx, about developing a Risk Evaluation and Mitigation Strategy (REMS) that clinicians will consider useful and that would raise their intent to prescribe.
Recently, ParagonRx collaborated with the Drug Safety Executive Counsel (DSEC) to sponsor a webinar.