U.S. Food and Drug Administration | Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 3 @US_FDA | Uploaded 3 weeks ago | Updated 2 hours ago
Content in this video provided updates and cutting-edge insight on novel artificial intelligence (AI), clinical trial designs and innovative strategies, safety data in clinical trials, combination products, electronic submissions and more. Subject matter experts provided insight on FDA’s perspectives, adoption of regulatory guidelines, opportunities for stakeholders to engage with CDER and best practices.
Timestamps
00:38 – Reimagining Clinical Research: The Transformation of Trial Design & Conduct
41:01 – Q&A Session
49:47 – Advanced Manufacturing Technologies (AMT) Designation Program
01:20:52 – Q&A Session
Speakers:
Dave Burrow, PharmD, JD
Director
Office of Scientific Investigations (OSI)
Center for Drug Evaluation and Research (CDER) | FDA
Ranjani Prabhakara, PhD
Policy Lead
Office of Policy for Pharmaceutical Quality (OPPQ)
Office of Pharmaceutical Quality (OPQ)
CDER | FDA
Learn more at: fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2024-innovation-medical-product-development
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Upcoming Training - fda.gov/cdersbia
SBIA Listserv - public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist - youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA LinkedIn - linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - fda.gov/cdersbialearn
Twitter - twitter.com/FDA_Drug_Info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
Content in this video provided updates and cutting-edge insight on novel artificial intelligence (AI), clinical trial designs and innovative strategies, safety data in clinical trials, combination products, electronic submissions and more. Subject matter experts provided insight on FDA’s perspectives, adoption of regulatory guidelines, opportunities for stakeholders to engage with CDER and best practices.
Timestamps
00:38 – Reimagining Clinical Research: The Transformation of Trial Design & Conduct
41:01 – Q&A Session
49:47 – Advanced Manufacturing Technologies (AMT) Designation Program
01:20:52 – Q&A Session
Speakers:
Dave Burrow, PharmD, JD
Director
Office of Scientific Investigations (OSI)
Center for Drug Evaluation and Research (CDER) | FDA
Ranjani Prabhakara, PhD
Policy Lead
Office of Policy for Pharmaceutical Quality (OPPQ)
Office of Pharmaceutical Quality (OPQ)
CDER | FDA
Learn more at: fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2024-innovation-medical-product-development
-----------------------
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Upcoming Training - fda.gov/cdersbia
SBIA Listserv - public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist - youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA LinkedIn - linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - fda.gov/cdersbialearn
Twitter - twitter.com/FDA_Drug_Info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
