Скачать или смотреть REdI 2024 | D2S07 - The Advanced Manufacturing Technologies Designation Program

This presentation defined pharmaceutical quality and introduced the Advanced Manufacturing Technologies Designation Program. The session summarized feedback received from the Innovative Manufacturing Public Workshop and provided a comprehensive overview of the Advanced Manufacturing Technologies Designation Program Guidance. Key aspects of the program's implementation and benefits for pharmaceutical manufacturing innovation were discussed to support industry understanding of this regulatory pathway.

Timestamps

01:53 – What is Pharmaceutical Quality?

02:46 – Introduction to Advanced Manufacturing

05:34 – The Advanced Manufacturing Technologies Designation Program

10:36 – Next Step: 2023 Innovative Manufacturing Public Workshop

14:20 – The Advanced Manufacturing Technologies Designation Program DRAFT Guidance

30:16 – Summary

30:56 – Questions

Speaker:

Ranjani Prabhakara, PhD
Policy Lead
Office of Policy for Pharmaceutical Quality (OPPQ)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | FDA

Learn more at: https://www.fda.gov/drugs/news-events...

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