November 8-10, 2021 | Virtual Conference

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Agenda

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  • All
  • Monday, November 8, 2021
  • Tuesday, November 9, 2021
  • Wednesday, November 10, 2021
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

Janet Woodcock, M.D.
Acting 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. – 12:00 p.m. EST
Biosimilars Keynote Address

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

Noon – 1:00 p.m. EST
Networking Break
2:30 p.m. – 3:30 p.m. EST
3:30 p.m. EST
Day 1 Concludes
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
ORA Keynote Address

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

10:30 a.m. – 11:00 a.m. EST
OSE Keynote Address

Gerald Dal Pan, M.D., MHS
Director, Office of Surveillance and Epidemiology (OSE), CDER, FDA

11:00 a.m. – 12:00 p.m. EST
Networking Break
Noon – 1:30 p.m. EST
GRx+Biosims Learning Tracks
1:30 p.m. – 2:30 p.m. EST
2:30 p.m. – 3:30 p.m. EST
3:30 p.m. EST
Day 2 Concludes
9:00 a.m. – 9:30 a.m. EST
The Role of Quality in Accessible Medicines

Ronald Piervincenzi, PhD
Chief Executive Officer, United States Pharmacopeia

9:30 a.m. – 11:00 a.m. EST
Manufacturers’ Roundtable – Ensuring Biosimilars Sustainability

In this session, senior industry leaders will explore the sustainability of biosimilar development in the context of evolving manufacturing, policy and commercial considerations.

11:00 a.m. – 12:00 p.m. EST
Networking Break
Noon – 1:00 p.m. EST
2:30 p.m. – 3:30 p.m. EST
GRx+Biosims Workshop

*Agenda is subject to change

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