Learning Tracks

This session will explore evolving scientific approaches and regulatory expectations for sterility assurance submissions supporting generic and biosimilar sterile products, including drug-device combination products. Panelists will discuss current expectations for application content, format, and level of detail, as well as how tools such as Remote Record Assessments are shaping regulatory review and sponsor preparedness. The session will also address emerging issues such as low endotoxin recovery, plunger movement studies, vaporized hydrogen peroxide controls where applicable, and differing expectations for terminally sterilized and sterile-filtered products.

Shannon Heine, PhD
Senior Pharmaceutical Scientist, DPMAI, OPMA, OPQ, CDER, FDA

Arvind Mathuria, M.S.
Associate Director, Regulatory Affairs,  Cipla

Rajeev Mathur, PhD
Senior Vice President, Global head of Regulatory and Business Continuity, Sun Pharmaceuticals

Rumit Shah, MPharm
Associate Director Product Development, Apotex