Generic Drugs Forum 2022 – Day 1, Session 3 скачать в хорошем качестве

Generic Drugs Forum 2022 – Day 1, Session 3

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. 0:05 – Culture of Quality 28:54– Data Integrity in ANDA Submissions 48:49 – Data Integrity Issues from BA/BE Clinical Site Inspections: Case Studies and OSIS Evaluation Presenters and Panel: Nilufer Tampal Associate Director for Scientific Quality, Immediate Office | Office of Bioequivalence (OB) |Office of Generic Drugs (OGD) | CDER Shujun Chen Senior Pharmaceutical Quality Assessor, Division of Pharmaceutical Manufacturing II (DPMII), OPMA | Office of Pharmaceutical Quality (OPQ) | CDER Minglei Cui Commander, U.S. Public Health Service Team Leader, Division of Bioequivalence II (DBII), OB | OGD | CDER Cynthia (Yiyue) Zhang Senior Staff Fellow, Division of New Drug Study Integrity (DNDSI), Office of Study Integrity and Surveillance Session (OSIS), Office of Translational Sciences (OTS) | 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