Learning Tracks

Best Practices for Post-Approval Changes

Tuesday, October 22, 2024

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

Grand Ballroom A-E

This session will provide presentations on best practices for post-approval changes from chemistry, manufacturing, and controls (CMC) and bioequivalence (BE) perspectives. Discussion and case studies will include addressing areas that need clarification in the SUPAC guidance for oral solid drug products. The panel will specifically address potential and desired changes to the SUPAC guidance for modified release oral dosage form.

Moderator: Rajeev Mathur
Senior Vice President & Head Of Global Regulatory & Business Continuity, Sun Pharma

Andy Aguanno, BSc.
Manager, Global Regulatory Affairs, Liquids & Specialty Dosage, Apotex Inc.

David Awotwe-Otoo, PhD
Senior Pharmaceutical Quality Assessor, Division of Product Quality Assessment III, OPQA I, OPQ, CDER, Food and Drug Administration

Hongling Zhang, PhD
Director, Division of Bioequivalence II, OB, OGD, CDER, Food and Drug Administration

Panelist: Mayank Nagar
Vice President & Head – Technical Services and New Product Launches (North America), Dr. Reddy’s Laboratories Inc.