Agenda
9:00 AM — 12:30 PM
Regulatory Affairs: Part 1: The IND – Investigational New Drug12:30 PM — 1:30 PM
1:30 PM — 5:00 PM
Regulatory Affairs: Part 2: The IND Amendments9:00 AM — 12:30 PM
Regulatory Affairs: Part 3: Special Topics12:30 PM — 1:30 PM
1:30 PM — 4:45 PM
Regulatory Affairs: Part 4: Adverse Events and Quality Assurance9:00 AM — 12:30 PM
Regulatory Affairs: Part 5: The NDA – New Drug Application12:30 PM — 1:30 PM
1:30 PM — 4:30 PM
Regulatory Affairs: Part 6: Interactions with FDA9:00 AM — 1:00 PM
Regulatory Affairs: Part 7: Mock FDA Meeting12:00 PM — 1:00 PM
1:00 PM — 4:15 PM
Regulatory Affairs: Part 8: Post-NDA¿Tiene una cuenta?