Regulatory Affairs: The IND, NDA, and Post-Marketing

Attend this virtual training course to learn about FDA regulations and expectations for the content, submission and review of INDs and NDAs, and the importance of regulatory strategy.

Agenda

Day 1 Aug 16, 2021

7:00 AM — 8:00 AM

Introduction to Regulation of Drugs and Biologics in the United States: Pre-Course Part One

8:00 AM — 9:00 AM

Introduction to Regulation of Drugs and Biologics in the United States: Pre-Course Part Two

9:00 AM — 12:45 PM

Regulatory Affairs: Part 1: The IND – Investigational New Drug

12:45 PM — 1:30 PM

Lunch Break

1:30 PM — 5:15 PM

Regulatory Affairs: Part 2: The IND Amendments

5:15 PM — 6:15 PM

Virtual Reception

Day 2 Aug 17, 2021

9:00 AM — 12:30 PM

Regulatory Affairs: Part 3: Special Topics

12:30 PM — 1:15 PM

Lunch Break

1:15 PM — 5:00 PM

Regulatory Affairs: Part 4: Adverse Events and Quality Assurance

Day 3 Aug 18, 2021

9:00 AM — 12:00 PM

Regulatory Affairs: Part 5: The NDA – New Drug Application

12:00 PM — 12:45 PM

Lunch Break

12:45 PM — 5:30 PM

Regulatory Affairs: Part 6: Interactions with FDA

Day 4 Aug 19, 2021

9:00 AM — 12:15 PM

Regulatory Affairs: Part 7: Mock FDA Meeting

12:15 PM — 1:00 PM

Lunch Break

1:00 PM — 4:15 PM

Regulatory Affairs: Part 8: Post-NDA

Day 5 Aug 20, 2021

9:00 AM — 3:15 PM

Regulatory Affairs: Part 9: Regulatory Requirements and Post-Approval Workshop

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Regulatory Affairs: The IND, NDA, and Post-Marketing

Agenda

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