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Development of Shared System and Shared REMS: Best Practices and Lessons Learned
Session Chair(s)
Jacqueline Sheppard, PHARMD
Team Leader, OMEPRM, OSE, CDER, FDA, United States
This forum will focus on best practices and lessons learned for the development and implementation of Shared REMS. These topics will be discussed from the perspectives of the FDA, leaders in industry, and other stakeholders.
Learning Objective : Identify changes to the REMS statute through the Appropriations Act of 2020; Describe challenges for design and implementation during the development of Shared REMS; Describe processes and challenges for REMS that incorporate >1 product from a single applicant; Discuss best practices for the development of a shared REMS and incorporation of new products into an existing REMS program.
Speaker(s)
Laura Zendel, PHARMD
Team Leader, OMEPRM, OSE, CDER, FDA, United States
FDA Update
Kevin Holman, MBA, RAC
Head, North America Risk Management and Pharmacovigilance Compliance, Johnson & Johnson Innovative Medicine, United States
Industry Update
Kishore Gopu, MBA, MS
Senior Director, REMS Operations, Teva Pharmaceuticals, United States
Industry Update
Jemma Contreras, PHD
Executive Managing Director, Advisory Group Lead, Syneos Health, United States
Industry Update
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