AGENDA

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  • All
  • Monday, November 7, 2022
  • Tuesday, November 8, 2022
  • Wednesday, November 9, 2022
8:00 a.m. – 4:30 p.m. EST
Registration
8:00 a.m. – 9:00 a.m. EST
Networking Breakfast
9:00 a.m. – 9:30 a.m. EST
Welcome and Introduction

Dan Leonard
President and CEO, AAM

9:30 a.m. – 10:00 a.m. EST
Keynote Address
10:00 a.m. – 10:30 a.m. EST
FDA Commissioner Keynote Address

Robert Califf, M.D., MACC (invited)
Commissioner, Food and Drug Administration

10:30 a.m. – 11:00 a.m. EST
Networking Break
11:00 a.m. – 11:30 a.m. EST
CDER Keynote Address

Jacqueline Corrigan-Curay, JD, M.D.
Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), FDA

11:30 a.m. – Noon EST
Biosimilars Keynote Address

Sarah Yim, M.D.
Director, Office of Therapeutic Biologics and Biosimilars (OTBB), Office of New Drugs (OND), CDER, FDA

Noon – 1:30 p.m. EST
Networking Luncheon
1:30 p.m. – 3:00 p.m. EST
3:00 p.m. – 3:30 p.m. EST
Networking Break
3:30 p.m. – 4:30 p.m. EST
GRx+Biosims Learning Tracks
4:30 p.m. – 6:00 p.m. EST
Networking Reception
8:00 a.m. – 9:00 a.m. EST
Networking Breakfast
9:00 a.m. – 10:00 a.m. EST
OGD/OPQ/OC Keynote Address

Sally Choe, PhD
Director, Office of Generic Drugs (OGD), CDER, FDA

Michael Kopcha, PhD, RPh
Director, Office of Pharmaceutical Quality (OPQ), CDER, FDA

Donald Ashley, JD
Director, Office of Compliance (OC), CDER, FDA

10:00 a.m. – 10:30 a.m. EST
Networking Break
10:30 a.m. – 11:00 a.m. EST
ORA Keynote Address

Elizabeth Miller, PharmD
Assistant Commissioner for Medical Products and Tobacco Operations, Office of Regulatory Affairs (ORA), FDA

11:00 a.m. – 11:30 a.m. EST
General Sessions
11:30 a.m. – 1:00 p.m. EST
Networking Luncheon
1:00 p.m. – 3:00 p.m. EST
GDUFA III: What’s New, What Will it Mean for Industry, and an Update on FDA’s Implementation

Looking to get up to speed on GDUFA III? The FDA, AAM, and industry will discuss what’s new in GDUFA III, the agreement’s associated timelines, and key messages and content published in the commitment letter. FDA staff will provide presentations, touching on an overview of GDUFDA III, operations, legislation and policy, as well as meetings on generics.

3:00 p.m. –3:30 p.m. EST
Networking Break
3:30 p.m. – 5:30 p.m. EST
GRx+Biosims Exposition
5:30 p.m. – 6:30 p.m. EST
Networking Reception
6:30 p.m. – 10:00 p.m. EST
Dinner & Entertainment
7:30 a.m. – 8:30 a.m. EST
Networking Breakfast
9:00 a.m. – 9:30 a.m. EST
Fireside Chat

Moderator: Dan Leonard
President and CEO, AAM

Ronald Piervincenzi, PhD
Chief Executive Officer, United States Pharmacopeia

9:30 a.m. – 10:30 a.m. EST
Manufacturers’ Roundtable
10:30 a.m. – 11:00 a.m. EST
Networking Break
12:30 p.m. – 1:30 p.m. EST
Networking Luncheon
1:30 p.m. – 3:00 p.m. EST
3:00 p.m. EST
Conference Concludes

*Agenda is subject to change

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