Learning Tracks

USP monographs and testing methods have long been, and continue to be, used to demonstrate that a drug ingredient is what it is supposed to be. The combination of perceived intentional delays to slow updates to monographs and the challenges among ISO, USP, and manufacturer-developed testing methods are reported to hinder generic drug development and approval. This session will explore best-practices for all stakeholders to work together to maintain drug integrity while also ensuring patient access to generic drugs and provide an understanding of how USP standards (monographs and General Chapters) support the development of generic drugs. The session also will explain the intricacies involved in updating USP standards and how industry can participate and help USP with this process via USP’s volunteer groups, public calls for comment, and other types of stakeholder engagement.

Moderator: Scott Kuzner, PhD
Senior Director, Sciences and Regulatory Affairs, AAM

Speakers:
Pallavi Nithyanandan, PhD
Director, Compendial Operations and Standards Staff, OPPQ, OPQ, CDER, FDA

Shankari Shivaprasad, PhD
Principal Scientist, Small Molecules, USP

Houri Simonian-Houldsworth
Senior Director, Analytical R&D, Apotex

Alan Thompson
Director, Regulatory Affairs, Teva Pharmaceuticals