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/NDAs, and the importance of regulatory strategy.

会议日程

天 1 2020 年 08 月 17 日

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 — 12:30 PM

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

12:30 PM — 1:15 PM

Lunch Break

1:15 PM — 5:15 PM

Regulatory Affairs: Part 2: The IND Amendments

天 2 2020 年 08 月 18 日

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

天 3 2020 年 08 月 19 日

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 — 5:15 PM

Regulatory Affairs: Part 6: Interactions with FDA

天 4 2020 年 08 月 20 日

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

天 5 2020 年 08 月 21 日

9:00 AM — 2:15 PM

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

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

会议日程

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