Скачать или смотреть Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 1 - Part 3

CAPT Connie Jung, Senior Advisor for Policy in the Office of Drug Security, Integrity, and Response (ODSIR), reviews advances in drug supply chain security, focusing on the distribution of drugs in the U.S. Requirements under the Drug Supply Chain Security Act (DSCSA). Mary Ann Slack Director Office of Strategic Programs (OSP) explores FDA’s and CDER’s modernization goals and key initiatives, including an expansion on the IT/Informatics goals in PDUFA VII. J. Lowell Marshall of Office of Information Management Technology (OIMT) presents the phased approach of how ESG is modernizing its technology and enhancing the user experience. Norman Schmuff associate director of Office of Pharmaceutical Manufacturing Assessment (OPMA) describes FDA's efforts to create data standards for Electronic CTD-Q submissions for quality submissions to CDER, CBER, and CVM.


00:00 – Advances in Drug Supply Chain Security – Focus on Distribution (Includes question and answer session)
55:40 – IT and Informatics Goals – CDER’s Perspective
1:17:52 – Electronic Submissions Gateway (ESG) Transparency and Modernization
1:35:45 – Standardizing Quality Submissions and Assessments: PQ/CMC and KASA
1:56:40 – Question and Answer Panel


SPEAKERS:

Connie Jung, RPh, PhD
Captain, United States Public Health Service
Senior Advisor for Policy
Office of Drug Security, Integrity, and Response (ODSIR)
Office of Compliance (OC) | CDER

Mary Ann Slack
Director
Office of Strategic Programs (OSP) | CDER

J. Lowell Marshall, PMP, FAC-COR III
Office of Information Management Technology (OIMT)
Office of Digital Transformation (ODT)
Office of the Commissioner (OC)

Norman Schmuff
Associate Director
Office of Pharmaceutical Manufacturing
Assessment (OPMA)
Office of Pharmaceutical Quality (OPQ) | CDER

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

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