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DIA 2021 Global Annual Meeting

Development of Shared System and Shared REMS: Best Practices and Lessons Learned

Session Chair(s)

Jacqueline Sheppard, PharmD

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

FDA Update

Laura Zendel, PharmD

  • Team Leader, OMEPRM, OSE, CDER
  • FDA, United States
Kevin Holman, MBA, RAC

Industry Update

Kevin Holman, MBA, RAC

  • Head, REMS and Risk Management
  • Janssen Pharmaceuticals, United States
Kishore Gopu, MBA, MS

Industry Update

Kishore Gopu, MBA, MS

  • Director, REMS Operations
  • Teva Pharmaceuticals, United States
Jemma Contreras, PhD

Industry Update

Jemma Contreras, PhD

  • Executive Managing Director, Advisory Group Lead
  • Syneos Health, United States