Learning Tracks

This session will examine opportunities to modernize post-approval change requirements through a more predictable, risk-based, and science-driven framework. Panelists will discuss best practices for post-approval chemistry, manufacturing, and controls (CMC) and bioequivalence (BE) changes, including broader use of comparability protocols, expanded PAC classifications that better reflect product and process knowledge, and increased reliance on harmonized global standards such as ICH Q12. The discussion will also explore areas where additional guidance may be needed, including post-approval changes for complex dosage forms such as transdermal patches, MDIs, DPIs, and peptide drug products, as well as potential updates to SUPAC guidances following FDA’s March 2026 request for input. This session will also cover best practices for effective communication with FDA.

Moderator: Michael Balon, BSc,
Senior Director, Regulatory Affairs, Apotex Inc.

Dhaval Desai
Director, Regulatory Affairs, Zydus Pharmaceuticals (USA)

Tina Kiang, PhD
Director, Division of Regulations and Guidance, OPPQ, OPQ, CDER, FDA

Vidula Kolhatkar, Ph.D.
Pharmacologist, DBII, OB, OGD,CDER, FDA

Veeranna Lolla
Director, Regulatory Affairs, Sandoz Inc.

Umesh Pai, MPharm
Associate Vice President of Manufacturing Science & Technology Group (MSTG), Regulatory & Business Continuity, and U.S. Agent, Sun Pharmaceuticals

CDR Lana Rossiter, PhD
Supervisor, OPRO, OPQ, CDER, FDA