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July 14, 2010

Wednesday FoREMS: Considering A Drug Safety Perspective of REMS In the July edition of Wednesday FoREMS, we will focus on the Drug Safety perspective, using those analytics and skills to define the benefit-risk profile of a medication and lead the implementation of a REMS

Wednesday FoREMS discussion

July 14, 2010 at 12:00 PM Eastern Time

Considering A Drug Safety Perspective of REMS

Inherently, REMS is a cross-disciplinary activity, requiring the participation and insights of many functional groups to be successful.  Each function has a specific perspective that is essential to designing and implementing an effective risk mitigation plan.  In the July edition of Wednesday FoREMS, we will focus on the Drug Safety perspective, using those analytics and skills to define the benefit-risk profile of a medication and lead the implementation of a REMS.

Billy Holden, Chief Safety Officer of ParagonRx, will present a 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.  Billy will present an overview of quantitative methods that can be used to improve benefit-risk characterization and communication.  This is an extensive topic to be covered in a brief presentation, so the focus will be on an overview of the methods and a case study for practical application.

Rekha Garg, Executive Director of Risk Intervention Strategy and Communication at Amgen, will present her experiences leading the implementation of multiple REMS.  She will share a model in which a strong centralized organization functionally aligned with Drug Safety and Regulatory Compliance can lead a cross-functional implementation plan that requires the cooperation and commitment of many individuals across the company.

To join us for this session, please register for the Wednesday FoREMS webinar series.


To speak to a ParagonRx team member about our monthly webinars
call 888.459.8080 or email info@paragonrx.com