CDER BIMO GCP Compliance and Enforcement Published 2022-02-24 Download video MP4 360p Download video MP4 720p Recommendations 1:56:59 Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA 1:31:45 Conversations on Cancer: Living with Metastatic Breast Cancer 1:54:55 Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 4 1:31:24 Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 2 6:01:12 NanoDay Symposium on Continuous Manufacturing of Nanomaterials 2023 22:14 Synthetic Therapeutic Peptide APIs: Documentation for API Sameness & Related Impurities 1:38:58 Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 1 27:35 Health Equity Research in Puerto Rico: A Conversation with Darlene I. Santiago Quiñones 1:15:00 Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 3 01:00 Science isn’t spooky at all… even though we have “phantoms” in our mammography lab. 57:01 Decentralized Clinical Trials (DCT) Draft Guidance 49:22 FSMA Chat: Introduction to the Food Defense Inspection Team 22:55 Product Quality Testing for Topical Ophthalmic Suspension Products (18of39) Complex Generics 2018 01:08 Our Scientists Helping to Make Sure Mammography Machines Are Safe and Effective | Researching FDA 52:13 FDA Drug Topics - Regulatory Framework for Human Drug Compounding 18:45 Protecting Patients & Consumers from Drug Quality Risks 01:06 What Does FDA Do? 02:07 About Formaldehyde and Formaldehyde-Releasing Chemicals 06:41 CFSAN Superheroes 04:03 King for STEM Day Similar videos 1:07:11 2019 CCTS FDA Conference - CDER BIMO Compliance and Enforcement 02:43 BIMO: US FDA BIMO Compliance Program 8:05:36 Electronic Drug Registration and Listing (eDRLS) Using CDER Direct 06:46 FDA’s Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors 1:10:40 BIMO, REMS, and PADE Inspection Readiness (3of3) Jun. 19, 2018 40:47 Overview of Clinical Investigator Responsibilities and Inspectional Findings (11/14) REdI 2017 06:08 FDAs BIMO Program: Inspection of Sponsors, CROs, and Monitors 06:32 Inspection Readiness: Understanding BIMO Inspection Req. for Sponsors, CROs, Monitors, Investigators 06:32 Inspection Readiness: Understanding BIMO Inspection Requirements for Sponsor/CRO/Monitor/ Invest 1:18:40 CDER’s Role in Public Health Emergency Response and Medical Countermeasure Development 45:10 Unblinding – Let Me Count the Ways… (8of11) GCP Data Integrity 23:22 Data Integrity from International Perspectives (2of11) GCP Data Integrity Workshop 39:09 Walkthrough of an FDA Clinical Investigator Site Inspection (12/14) REdI 2017 41:38 FDA’s Bioresearch Monitoring Program - Foreign Inspections and Program Updates 06:50 FDA's BIMO Program: Inspection of Sponsors, CROs, & Monitors Trailer 34:02 Preparing for FDA Remote Inspections 1:27:33 Quality Management Maturity Program 2022 Public Workshop - Part 1 - Session 2 52:33 FDA Drug Manufacturing Inspections - REdI 2020 More results