FDA-NIH 2024 | D1S13 – Q&A Discussion Panel 2 скачать в хорошем качестве

FDA-NIH 2024 | D1S13 – Q&A Discussion Panel 2

The second of three Q&A discussion panels from the FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA 2024 conference. **No Timestamps** Panelists: Loni Warren Henderson Public Affairs Specialist Manufacturers Assistance and Technical Training Branch Division of Manufacturers Assistance and Training Office of Communication Outreach and Development | CBER Heather Erdman, MCPM, RAC, CQPA Associate Director of Quality Assurance Office of Review Management and Regulatory Review (ORMRR) Office of Therapeutic Products (OTP) | CBER Karin Knudson, PhD CMC Reviewer Office of Cellular Therapy and Human Tissue CMC (OCTHT) OTP | CBER Devaveena Dey, PhD Pharmacology-Toxicology Reviewer Office of Pharmacology-Toxicology (OPT) | OTP | CBER Jessica Lee, MD, PhD Branch Chief for the Oncology Branch 2 (OB2) Division of Clinical Evaluation Oncology (DCEO) Office of Clinical Evaluation (OCE) | CBER Peter F. Bross, MD Chief, Oncology Branch OTP | CBER Learn more at: https://www.fda.gov/drugs/news-events... ----------------------- 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 - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2024 Playlist -    • 2024 CDER Small Business and Industry Assi...   SBIA 2025 Playlist -    • 2025 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367