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 Amendments12:05 PM — 12:50 PM
9:00 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-NDA Submission and Approval9:00 AM — 12:30 PM
Regulatory Affairs: Part 9: Labeling, Promotion and Regulatory Intelligence12:30 PM — 1:15 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: | |
---|---|---|
Virtual Event Price | $1,400.00 | $1,725.00 |
オンライン
Review the CMC sections of regulatory submissions, the FDA inspection process, and how to avoid or minimize 483s (noncompliance) with this on-demand course.
会員価格: | 非会員価格: | |
---|---|---|
Virtual Event Price | $1,800.00 | $2,125.00 |
オンライン
Complete this On-Demand Training Course to learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.
会員価格: | 非会員価格: | |
---|---|---|
Virtual Event Price | $3,545.00 | $3,870.00 |