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Generic Drug Cluster – FDA Global Efforts

Wednesday, November 10, 2021

12:00 p.m. - 1:00 p.m.

FDA announced FDA’s Global Generic Drug Affairs program and the launch of the Generic Drug Cluster, the first forum with the world’s leading regulatory agencies established for generic drugs. The Generic Drug Cluster will increase scientific alignment among leading generic drug regulatory agencies. This session will discuss efforts on global coordination and collaboration for generic drugs.

Moderator: Susana Almedia, PhD
Clinical Development and Safety Director, Medicines for Europe

Sarah Ibrahim, PhD
Associate Director for Global Regulatory Affairs, Immediate Office, OGD, CDER, FDA

Nilufer Tampal, PhD
Associate Director of Scientific Quality, OB, OGD, CDER, FDA

Lei Zhang, PhD
Deputy Director, ORS, OGD, CDER, FDA

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