Dan Leonard
President and CEO, AAM

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

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

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

Best Practices for First Cycle Approvals for Abbreviated New Drug Applications (ANDAs)

Combination Products and Similarity

The Evolution of Biosimilars Assessments: Clinical to Non-Clinical

Nitrosamines in Pharmaceutical Manufacturing

Forecasting the Future of Advanced Manufacturing Technologies

Interchangeability

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

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

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.

How Has the COVID-19 Pandemic Shaped FDA Inspections and What’s on the Horizon?

pH Adjusters and Q1/Q2 Assessments

The Use of Real-World Data and Real-World Evidence in Decisions about Biosimilars and Interchangeable Biologics

Moderator: Dan Leonard
President and CEO, AAM

Ronald Piervincenzi, PhD
Chief Executive Officer, United States Pharmacopeia

Complex Generics: An Inside Look from the Agency

The Importance of Industry, Agency, and Other Key Stakeholder Engagement in USP’s Public Standard Development Process

BsUFA III: What’s New, What Will it Mean for Industry and FDA, and an Update on FDA’s Implementation Plan

The Patient Voice in Generic Drug Development

Regulatory Barriers to Post-Approval Changes for Complex Generic Drugs

Comparison of the U.S., Europe, and other Key Markets and Regulatory Harmonization for Biosimilars