Event Date/Time: Sep 18, 2006 End Date/Time: Sep 20, 2006
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Description

The course will focus on drug and well-characterized biological products and not the regulatory process for devices or generic products. This course describes the regulatory background of the IND and provides an overview of preparing an IND for submission to the FDA.

Key Topics
•Overview of FDA.
•Regulatory requirements for drug development.
•Roles and responsibilities of FDA.
•Pertinent regulatory processes and forms (Investigational New Drug applications [INDs], etc.).

Venue

201 S Christopher Columbus Blvd
Philadelphia
Pennsylvania
United States
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