Learning Tracks

This session will offer practical tips for interacting with FDA project managers, including when sponsors should reach out to the PM plus when and how to elevate issues beyond the PM. Learn about how to get the most out of correspondences. Learn how to approach a meeting with the FDA and how best to turn meeting feedback into positive results. Learn about late-stage issues, what they are and what can be done to improve chances of a timely approval.

In addition, learn about recent eCTD validation updates affecting submissions that contain study data (also know as the Technical Rejection Criteria for Study Data) and the most common reasons behind validation failure. These Technical Rejection Criteria can impact your submissions ability to  receive an ANDA filing review/assessment.

Moderator: Scott Tomsky
Associate Vice President, Global Regulatory Affairs CMC, Established Brands Franchise, Organon

Dawn Culp
Vice President, US Regulatory Affairs, Hikma Pharmaceuticals

LCDR David Eng, PharmD
Team Leader, Division of Project Management, ORO, OGD, CDER, FDA

Heidi Lee, PharmD
Branch Chief, Division of Regulatory and Business Process Management II, Office of Program and Regulatory Operations, OPQ, CDER, FDA

LCDR Cassandra Metu, PharmD, MS, PMP, RAC
Senior Regulatory Project Manager, Division of Project Management, ORO, OGD, CDER, FDA

Allison Schaefer, MS
Regulatory Project Manager, Division of Project Management, ORO, OGD, CDER, FDA

Jonathan Resnick 
Project Management Officer, Electronic Submissions Capability Team, DDMSS, OBI, OSP, CDER, FDA

Panelist:
CDR Chitra Mahadevan, PharmD, MS, BCPS, PMP
Director, Division of Bioequivalence Process Management, OB, OGD, CDER, FDA