Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - Day 1 – Welcome & Session 1

Sean Kassim, PhD, Director of Office of Study Integrity and Surveillance (OSIS) and ShaAvhrée Buckman-Garner, MD, PhD, Director, Office of Translational Sciences (OTS) deliver the welcome and keynote address to the Office of Study Integrity and Surveillance Workshop 2022. Tahseen Mirza, PhD Associate Director for Regulatory Affairs within OSIS, provides an overview of the mission, vision and role of OSIS in overseeing the Good Laboratory Practice, Animal Rule, and Bioavailability/ Bioequivalence Compliance Programs. Zhou Chen, MD, PhD, Erin McDowell, and Lynda Lanning, DVM, DABT present Session One: Overview of Good Laboratory Practice (GLP) Regulations and Compliance Programs. 00:00 – Welcome by Office of Study Integrity and Surveillance (OSIS) 03:13 – Keynote 08:12 – OSIS - Introduction, Mission, Vision 23:50 – Good Laboratory Practice (GLP) 101 - Regulation and Basic Studies 44:52 – GLP Compliance Program 1:04:00 – Inspection of Nonclinical Laboratories Conducting Animal Rule Specific Studies Compliance Program 1:24:18 – GLP Related Guidance Update: Pathology Peer Review and Whole Slide Imaging 1:30:15 – Session One Questions & Answer Panel SPEAKERS: Sean Kassim, PhD Director Office of Study Integrity and Surveillance (OSIS) Office of Translational Sciences (OTS) | CDER ShaAvhrée Buckman-Garner, MD, PhD Director Office of Translational Sciences (OTS) | CDER Tahseen Mirza, PhD Associate Director for Regulatory Affairs OSIS | OTS | CDER Zhou Chen, MD, PhD Team Lead, GLP Team Division of New Drug Study Integrity (DNDSI) OSIS | OTS | CDER Erin McDowell Biologist DNDSI | OSIS | OTS | CDER Lynda Lanning, DVM, DABT Biologist, GLP Team DNDSI | OSIS | OTS | CDER 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 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