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

Attend this live, 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.

Send Email 1.888.257.6457

Agenda

Día 1 01 ago 2024

8:30 AM — 9:30 AM

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

Día 2 19 ago 2024

9:00 AM — 12:45 PM

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

12:45 PM — 1:30 PM

Lunch Break

1:30 PM — 5:30 PM

Regulatory Affairs: Part 2: IND Amendments

Día 3 20 ago 2024

9:00 AM — 12:05 PM

Regulatory Affairs: Part 3: Special Topics and Adverse Event Reporting in Clinical Research

12:05 PM — 12:50 PM

Lunch Break

12:50 PM — 5:15 PM

Regulatory Affairs: Part 4: Special Regulatory Programs and Quality Assurance in Drug Development

Día 4 21 ago 2024

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

Día 5 22 ago 2024

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 Submission and Approval

Día 6 23 ago 2024

9:00 AM — 12:30 PM

Regulatory Affairs: Part 9: Labeling, Promotion and Regulatory Intelligence

12:30 PM — 1:15 PM

Lunch Break

1:15 PM — 3:30 PM

Regulatory Affairs: Part 9: Labeling, Promotion and Regulatory Intelligence (Continued)

¿Tiene una cuenta?

Eventos relacionados

Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process

			Precio del miembro:	Precio no socios:
Virtual Event Price			$1,800.00	$2,125.00

Regulatory Affairs: The IND, NDA, and Post-Marketing On-Demand Training

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

Agenda

Eventos relacionados

Be informed and stay engaged.