Learning Tracks

This session will examine evolving scientific and regulatory approaches to establishing bioequivalence for complex generic drug products, with a focus on long-acting injectables and other complex dosage forms. Panelists will discuss how in vitro, model-informed, analytical, and performance-based approaches may reduce reliance on large, lengthy clinical endpoint or pharmacokinetic studies while maintaining robust standards for quality, safety, efficacy, and therapeutic equivalence. The session will also highlight recent and revised FDA product-specific guidances that have enabled more flexible, science-based pathways across complex APIs, peptides and oligonucleotides, orally inhaled and nasal products, topical and locally acting products, and complex drug-device combination products.

Moderator: Gina Sirianni, MSc
Senior Director, Regulatory Affairs, Apotex Inc.

Darshan Aigal, M.S.
Director, Regulatory Affairs, Cipla

Young Jhon, PhD
Senior Chemist, DPQA IV, OPQA I, OPQ, CDER, FDA

Eunjung Park, PhD
Lead Pharmacologist, DBII, OB, OGD, CDER, FDA

Yan Wang, PhD
Deputy Division Director, DTPI, ORS, OGD, CDER, FDA