Event Date/Time: Mar 26, 2007 End Date/Time: Mar 27, 2007
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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.

•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

Broad and Walnut Streets
Philadelphia
Pennsylvania
United States
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