Regulatory II: The CTD/NDA Phase
Venue: Park Hyatt Philadelphia at the Bellevue
Location: Philadelphia, Pennsylvania, United States
Event Date/Time: Aug 28, 2006 | End Date/Time: Aug 30, 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.