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Learning Tracks

Improving Collaboration for REMS

Monday, November 8, 2021

2:30 p.m. - 3:30 p.m.

Negotiating shared system REMS between generics and brand drug manufacturers presents challenges to generic drug applicants. These negotiations usually include a REMS program agreement (RPA), which establishes the structure and governance rules for a shared system REMS program, and a reciprocal confidentiality agreement (CDA) under which parties to the negotiations can share confidential information with each other before the RPA is signed. This session will include a review of RPA and CDA templates and a discussion of ways to foster collaboration between generic and brand drug manufacturers with respect to REMS.

Moderator: Rachel Turow, JD, MPH
Associate General Counsel, Regulatory Law & Policy Head, U.S. Regulatory Policy, Teva

Kishore Gopu, MS, MBA
Director, REMS Operations, Teva Pharmaceuticals

Elaine Lippmann, JD
Senior Regulatory Counsel, Office of Regulatory Policy (ORP), CDER, FDA

Claudia Manzo, PharmD
Director, Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology (OSE), CDER, FDA

Suzanne McLeod
Manager, REMS and Drug Safety, Hikma Pharmaceuticals

Adam Steinberg, PharmD
Manager, Regulatory Affairs, Apotex Corp.

Panelist:
Lauren Ciurca, JD
Acting Director, Division of Legal and Regulatory Support, Office of Generic Drug Policy (OGDP), OGD, CDER, FDA

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