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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)
FDA Update
Laura Zendel, PharmD
FDA, United States
Team Leader, OMEPRM, OSE, CDER
Industry Update
Kevin Holman, MBA, RAC
Johnson & Johnson Innovative Medicine, United States
Head, US Risk Management and Pharmacovigilance
Industry Update
Kishore Gopu, MBA, MS
Teva Pharmaceuticals, United States
Senior Director, REMS Operations
Industry Update
Jemma Contreras, PhD
Syneos Health, United States
Executive Managing Director, Advisory Group Lead
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