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 — 12:45 PM
Regulatory Affairs: Part 3: Special Topics12:45 PM — 1:30 PM
1:30 PM — 5:15 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
関連イベント
オンライン
Register for this On-demand Training Course training course to learn about FDA's approach to regulation of combination products, the processes to streamline development of single entity, and aligning requirements between drugs and devices.
会員価格: | 非会員価格: | |
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Virtual Event Price | $1,400.00 | $1,725.00 |