会议日程
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
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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.
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Review the CMC sections of regulatory submissions, the FDA inspection process, and how to avoid or minimize 483s (noncompliance) with this on-demand course.
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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.
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