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Learning Tracks

Innovation in Generic Drug Development and Assessment

Wednesday, November 10, 2021

1:00 p.m. - 3:00 p.m.

Generic drug development can benefit from innovations such as emerging technologies and advanced manufacturing to produce high-quality drug products consistently. In addition, novel technologies, methodologies or models for demonstration of Bioequivalence (BE) can also facilitate development of generic products, especially complex generics. The agency is also using innovating tools such as Knowledge-aided Assessment & Structured Application (KASA) and Quality Management Maturity (QMM) to assess and monitor the quality of drug products. This session will focus on these innovations in generic drug development and assessment.

Moderator: Mike Balon
Global Director, Regulatory Affairs, Apotex Inc.

Clare Butler, PhD
Head of IVIVC Global Inhalations, Teva Pharmaceuticals

Dapeng Cui, PhD 
Reviewer, Division of Bioequivalence I, OB, OGD, CDER, FDA

CDR Lyle Canida, PharmD, MS, CPH 
Regulatory Operations Officer, OPQ, CDER, FDA

Thomas O’Connor, PhD
Division Director, Division of Product Quality Research, Office of Testing and Research, OPQ, CDER, FDA

Larisa Wu, PhD
Acting Associate Director of Science and Communication, Office of New Drug Products, OPQ, CDER, FDA

Miyoung Yoon, PhD
Acting Team Leader, Division of Quantitative Methods & Modeling, ORS, OGD, CDER, FDA

Liang, Zhao, PhD
Director, Division of Quantitative Methods & Modeling, ORS, OGD, CDER, FDA

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