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 |
Description
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.