Learning Tracks

This session will examine how evolving quality approaches and regulatory flexibility can support more resilient generic and biosimilar supply chains while maintaining product quality, safety, and compliance. Panelists will discuss practical regulatory and CMC considerations for timely drug product site transfers across global manufacturing networks, including comparability strategies, post-approval change pathways, and risk-based approaches leveraging ICH Q12. The session will also explore broader quality and supply solutions, including Quality Management Maturity, advanced manufacturing, inspection and surveillance policies, and other approaches that may strengthen supply reliability for generic and biosimilar medicines. This panel will also touch on supply chain resiliency and third-party testing.

Moderator: Kristin Willemsen, MSc 
Vice President, Scientific & Regulatory Affairs, Canadian Generic Pharmaceutical Association

CAPT Qiao Bobo, PhD, RAC
Division Director, DPMAV, OPQMA, OPQ, CDER, FDA

Anand Saxena, MSc
Director, Regulatory Affairs,  Cipla

Gregory Seitz
Head, U.S. Regulatory Affairs, Generics, Sandoz

Eric Twum, PhD
Regulatory Specialist, DQI-II, OQS, OPQ, CDER, FDA