Are the risk mitigation measures within a REMS (Risk Evaluation and Mitigation Strategy) adequate enough to ensure optimal benefit-risk management? Even if the FDA doesn’t require a REMS for a product, does it make sense to undertake risk management measures anyway? (more…)
Posts Tagged ‘risk mitigation’
Complimentary Webinar to Address: Is a ‘Voluntary REMS’ a Good Risk?
Monday, April 11th, 2011REMS Coordination Office
Monday, April 26th, 2010The REMS Coordination Office (RCO) is the organizing hub among a Sponsor’s cross-functional team. The RCO is responsible for coordinating and tracking various aspects of REMS and the activities of outside service providers. The RCO features a core team of individuals tasked with managing REMS activities and processes.
This was the topic of a recent webinar hosted by ParagonRx. Jeff Fetterman, ParagonRx President, opened the webinar by borrowing two examples from the nuclear industry to illustrate how two different principles for organizing operational processes and systems have the potential for two different outcomes – flawless or disastrous. (more…)
Organizing for REMS Effectiveness: A View from the Field
Tuesday, March 30th, 2010- Guest blog by Andrea J. Simon, PhD -
This blog by Andrea Simon, PhD, a corporate anthropologist, is one in a series that ParagonRx has initiated to help our readers better understand some of the trends taking place in the field of Risk Evaluation and Mitigation Strategies (REMS) and risk management under the FDA draft guidance. We know you will find them of value and encourage you to comment on them.
In April, ParagonRx is hosting its Wednesday FoREMS webinar on the topic of organizing to effectively manage Risk Evaluation and Mitigation Strategies (REMS). And, in May, the Wednesday FoREMS will host a panel of industry leaders discussing how their organizations are building REMS capabilities and resourcing them in their product development and commercialization functions. In preparation for these upcoming webinars, I thought I would share with you some of my observations from the field and encourage you to share your own company’s perspectives on how you are reorganizing to create and effectively manage REMS. (more…)
Airplanes and Medications
Thursday, September 3rd, 2009Airplanes and medications seem like items that don’t mix well. In fact, the discussion of a recent webinar suggests otherwise, at least as it relates to risk management. Captain Ben Berman shared experiences from his role as former Chief of Major Investigations of the U.S. National Transportation Board in which he served as a member of the major accident go-team responsible for safety studies about flight crew human factors. (more…)
REMS Programs for Opioid Drugs?
Thursday, February 19th, 2009REMS programs for opioid drugs? A worthy approach but many questions remain to be answered.
Developing an effective REMS program – one designed to preserve access for every person who would benefit from a medication while avoiding exposure in situations and individuals with excessive risk factors – is a challenge. The difficulty increases when the risks expand beyond inadvertent misuse to also include intentional abuse.
Recently the FDA signaled its intent to tackle risks involving opioids that have both significant benefits for certain segments of patients and also the potential for misuse and abuse. On March 3, the FDA will sit down with 15 manufacturers of 24 opioid medications to begin the process of outfitting them with REMS.
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Thoughts Shared at FDLI Risk Management Conference
Wednesday, January 28th, 2009FDA and the industry share thoughts at FDLI risk management conference
Earlier this month, while Washington was bustling with Inaugural preparations, there was an excellent meeting in the capital on pharmaceutical risk management, hosted by the Food and Drug Law Institute (FDLI) at the offices of Morgan, Lewis & Bockius LLP. The impetus of the meeting was to provide a forum for some of the authors of the recently published text, Pharmaceutical Risk Management: Practical Applications (FDLI, 2008) as well as other experts within the industry and within the FDA. Industry veteran Wayne Pines, who edited the book along with me and my colleague at ParagonRx, Gary Slatko, chaired the conference.
I would like to share with you some of the more-intriguing thoughts to come out of the conference, as well as a few news tidbits – but first let me say that if you would like to obtain a complete transcript of the conference or to buy a copy of PRM: Practical Applications, please contact the FDLI website at www.fdli.org.
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