Regulatory II: The CTD/NDA Phase

Venue: Washington Marriott Hotel

Location: Washington, District Of Columbia, United States

Event Date/Time: Nov 13, 2006 End Date/Time: Nov 15, 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, or the abbreviated NDA. This course describes the regulatory background of the NDA and provides an overview of preparing an NDA in CTD format for submission to the FDA.

Key Topics
•Overview of FDA.
•Roles and responsibilities of FDA.
•Regulatory requirements for drug approval.
•Pertinent regulatory processes and forms.
•Overview of the CTD format.
•Post-approval and marketing regulatory requirements and processes.

Venue

1221 22nd Street NW
Washington
United States
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