Learning Tracks

Best Practices for Post-Approval Changes

Tuesday, October 3, 2023

1:15 p.m. - 2:30 p.m.

This Session will provide presentations on best practices for post-approval chemistry, manufacturing, and controls (CMC) and bioequivalence (BE) changes. Discussion and cases will include addressing areas needing guidance including post-approval changes to complex dosage forms such as Transdermal patches, MDI, DPI, and peptide drug products.

Speakers:

David Awotwe-Otoo, PhD
Senior Pharmaceutical Quality Assessor (SPQA), Division of Pharmaceutical Manufacturing Assessment II, OLDP, OPQ, CDER, FDA

CDR Lana Rossiter, PhD
Branch Chief, Division of Regulatory and Business Process Management III, OPRO, OPQ, FDA

Gina Sirianni, MSc
Director, Global Regulatory Affairs Co-Development, Apotex Inc.

Diana Vivian, PhD
Associate Director, Division of Bioequivalence II, OB, OGD, CDER, FDA

Janet Vaughn
Vice President, North America Generic Regulatory Affairs, Teva Pharmaceuticals USA

Panelists:

CDR Andrew Fine, PharmD
Senior Advisor, Division of Clinical Review, OSCE, OGD, CDER, FDA

Hongling Zhang, PhD
Division Director, Division of Bioequivalence II, OB, OGD, CDER, FDA

Yan Wang, PhD
Team Leader, Division of Therapeutic Performance I, ORS, OGD, CDER, FDA