アジェンダ
9:00 AM — 12:45 PM
Regulatory Affairs: Part 1: The IND – Investigational New Drug Application12:45 PM — 1:30 PM
1:30 PM — 5:30 PM
Regulatory Affairs: Part 2: IND Amendments9:00 AM — 12:30 PM
Regulatory Affairs: Part 3: Special Topics12:30 PM — 1:15 PM
1:15 PM — 5:00 PM
Regulatory Affairs: Part 4: Adverse Events and Quality Assurance9:00 AM — 12:00 PM
Regulatory Affairs: Part 5: The NDA – New Drug Application12:00 PM — 12:45 PM
12:45 PM — 5:30 PM
Regulatory Affairs: Part 6: Interactions with FDA9:00 AM — 12:15 PM
Regulatory Affairs: Part 7: Mock FDA Meeting12:15 PM — 1:00 PM
1:00 PM — 4:15 PM
Regulatory Affairs: Part 8: Post-NDA9:00 AM — 12:45 PM
Regulatory Affairs: Part 9: Labeling, Promotion and Regulatory Intelligence12:45 PM — 1:30 PM