Regulatory Affairs Part I: The IND Phase

Venue: Drug Information Association, Inc.

Location: Horsham, Pennsylvania, United States

Event Date/Time: Sep 13, 2010 End Date/Time: Sep 15, 2010
Report as Spam

Description

Learn how to apply regulatory concepts to ensure compliant IND submissions to FDA. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.



WHAT YOU WILL LEARN

· Overview of the drug development process

· The IND process

· Quality assurance in drug development (GXPs)

· FDA’s actions on the original IND and amendments

· Activities and submissions after the original IND

· How to interact with FDA

· Procedures for reporting adverse events (AEs)

Event Code:
10456

Venue

800 Enterprise Rd Ste 200
Horsham
Pennsylvania
United States
MORE INFO ON THIS VENUE