Regulatory I: The IND Phase

Venue: Chicago Marriott O\'Hare

Location: Chicago, Illinois, United States

Event Date/Time: Sep 17, 2007 End Date/Time: Sep 19, 2007
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Description

This course will offer insight into the regulatory background of the IND and outline the content and data requirements for an IND submission to FDA. The course will focus on drug and well-characterized biological products and not the regulatory process for devices, generic products or traditional biologics.

Course Highlights
•Overview of the drug development process
•IND process
•Quality assurance in drug development (GXPs)
•FDA's actions on the original IND and amendments
•Activities and submissions after the original IND
•Interaction with FDA
•Procedures for reporting adverse events (AEs)

Venue

8535 West Higgins Road
Chicago
Illinois
United States
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