Generic Drugs Forum 2022 – Day 1, Session 1 скачать в хорошем качестве

Generic Drugs Forum 2022 – Day 1, Session 1

FDA presents on the Current State of Generic Drugs and offers practical advice, presenting case studies, and taking a deep dive into the abbreviated new drug application assessment program. Presentations focus on topics such as the pre-ANDA program, generic drug metrics, post-market safety, pre-approval inspections, and global generic drug affairs. Includes Q&A session and a moderated panel discussion. 0.01 – Keynote 12.01 – Office of Generic Drugs Keynote 18:45 – Office of Pharmaceutical Quality Keynote 41:17 – Use of Knowledge-Aided Assessment and Structured Application (KASA) in Drug Product Assessment 1:03:16 - Use of Knowledge-Aided Assessment and Structured Application (KASA) in Drug Product Manufacturing Assessment 1:21:07 - Use of Knowledge-Aided Assessment and Structured Application (KASA) in Biopharmaceutics Assessment 1:40:57 – Integrated Drug Product Assessment: Expectations 2:01:32 – Questions & Panel Discussion Presenters and Panel: Janet Woodcock Principal Deputy Commissioner, Office of the Commissioner, FDA Sally Choe Director, Office of Generic Drugs (OGD) | CDER Michael Kopcha Director, Office of Pharmaceutical Quality (OPQ) | CDER Peter Capella Director, Division of Immediate and Modified Release Products II (DIMRPII), Office of Life Cycle Products (OLDP) |OPQ | CDER Rakhi Shah Associate Director, Office of Pharmaceutical Manufacturing Assessment (OPMA) | OPQ | CDER Kimberly Raines Branch Chief, Division of Biopharmaceutics, Office of New Drug Products (ONDP) | OPQ | CDER Mayra Pineiro Sanchez Senior Pharmaceutical Quality Assessor, Division of Immediate and Modified Release Products II, OLDP | OPQ | CDER For slides and additional information: 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 2022 Playlist -    • 2022 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 - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367