Learning Tracks

This session will expound on the current Transparency Pilot and how the agency is using this initiative to provide more information to the applicants and increased touchpoints along with standard communication tools. This session will also provide tips and strategies for the applicant when the application is nearing approval.

Participants:
John Derstine
Senior Director, Regulatory Affairs, Teva Pharmaceuticals

Karen Ireland, MS, PMP, RAC-Drugs
Supervisory Regulatory Health Project Manager, Division of Regulatory and Business Process Management II, OPRO, OPQ, CDER, FDA

Meenakshi Jain, MPharm
Senior Director and Head of Regulatory Generics Development, Sandoz

CAPT Vince Sansone, PharmD
Director, Division of Project Management, Office of Regulatory Operations (ORO), OGD, CDER, FDA

Moderator: Kiran Krishnan, PhD
Senior Vice President, Global Regulatory Affairs, Apotex Inc.