Learning Tracks

This panel discussion will explore the complex generic drug products FDA has approved and the regulatory science that can support further approvals, including related to comparative use human factors studies (CUHFS), immunogenicity, long-acting injectables, complex API characterization, and other scientific topics. Additionally, this session will cover developments related to complex generics, from both Agency and industry perspectives.

Moderator: Carrie O’Donel
Senior Principal Device Engineer, Teva Pharmaceuticals

Tarun Goswami, PhD
Senior Director, Complex Product Development, Amneal Pharmaceuticals

Vasiliy Korotchenko, PhD
Chemist, Division of Product Quality Assessment IV, OPQA I, OPQ, CDER, Food and Drug Administration

Keduo Qian, PhD
Chemist, Division of Product Quality Assessment XIX, OPQA III, OPQ, CDER, FDA

Kalpana Vanam, MBA
Senior Vice President, Regulatory Affairs, Lupin

Yan Wang, PhD
Acting Deputy Director, Division of Therapeutic Performance I (DTP), ORS, OGD, CDER, Food and Drug Administration

Panelist: Young Jhon, PhD
Senior Chemist, DPQAIV, OPQAI, OPQ, CDER, FDA