Wednesday FoREMS: Considering A Drug Safety Perspective of REMS
Wednesday, July 14th, 2010
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 session of Wednesday FoREMS, we 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, presents 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 presents 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, presents her experiences leading the implementation of multiple REMS. She shares 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.
Please Note: At the request of our guest speakers we will not be posting slides or a replay of our July session. If you would like additional information, please contact us.
