Generic Drugs Forum 2022 – Day 2, Session 4

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. 0:02 – Use of Alternate Tools for Inspections During the COVID-19 Pandemic 21:32 – Office of Quality Surveillance (OQS) and the Assessment of Pharmaceutical Quality Systems (PQS) in support of ICH Q12 44:58 – OPQ Policy Update – Guidance ICH Q12 Technical Considerations for Pharmaceutical Product Lifecycle Management 1:11:06 – Questions & Panel Discussion Presenters and Panel: Haitao Li Branch Chief, Office of Pharmaceutical Manufacturing Assessment (OPMA) | Office of Pharmaceutical Quality (OPQ) | CDER Alexander Gontcharov Staff Fellow, Office of Pharmaceutical Manufacturing Assessment (OPMA) | OPQ | CDER Alex Viehmann Division Director, Division of Quality Intelligence II, Office of Quality Surveillance (OQS), OPQ | CDER Ashley Boam Director, Office of Policy for Pharmaceutical Quality (OPPQ), 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 - [email protected] Phone - (301) 796-6707 I (866) 405-5367