Open Webinar Will Address Practical Aspects of Drug Safety Perspective of REMS Development

The practical aspects of utilizing a drug safety perspective in the development and implementation of Risk Evaluation and Mitigation Strategies (REMS) will be examined in a complimentary webinar for all interested parties this Wednesday, July 14, at 12 noon Eastern Time.

Entitled “Considering a Drug Safety Perspective of REMS,” the program will also celebrate the second-half of the year-long, monthly webinar series “Wednesday FoREMS” sponsored by ParagonRx, an inVentiv Health, Inc. company (NASDAQ:VTIV), and a leading consulting company specializing in pharmaceutical risk management and optimizing medication.

“Inherently, REMS is a cross-disciplinary activity, requiring the participation and insights of many functional groups to be successful,” says Jeffrey Fetterman, President of ParagonRx. “Each function has a unique perspective that is essential to designing and implementing an effective risk mitigation plan. This month we will delve into the Drug Safety perspective.”

Billy Holden, Chief Safety Officer of ParagonRx, will present a practical framework for quantitatively characterizing the benefit-risk profile of pharmaceutical products. Although all risk management is grounded in data arising from clinical trials and post marketing experience, too often the benefit-risk characterization and REMS design is qualitative in nature because risk and benefits are measured in different units, making a quantitative synthesis rather challenging.

Also presenting will be Rekha Garg, Executive Director of Risk Intervention Strategy and Communication at Amgen, who will discuss her company’s experiences leading the implementation of multiple REMS. She will share a model showing how a strongly centralized organization can functionally align with global safety, leading to a cross-functional implementation plan that requires the cooperation and commitment of many individuals across the company.

More information about registering for the “Wednesday FoREMS” webinar series can be found at www.paragonrx.com/rems-hub/forems/. Webinars will be held the second Wednesday of each month at 12 noon EDT.

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