FDA BIMO Program - FDA's GCP Compliance Review for NDAs and BLAs скачать в хорошем качестве

FDA BIMO Program - FDA's GCP Compliance Review for NDAs and BLAs

#FDA #BIMO Program - FDA's GCP Compliance Review for #NDAs and #BLAs 00:00 Intro 00:51 Bioresearch Monitoring Program 07:53 BIMO Program Compliance Programs 09:51 FDA’s GCP Inspection Process 11:35 FDA’s Organization - OSI 13:40 FDA’s Organization – OII 15:02 Study Data Standards Resources 16:58 Study Data Technical Conformance Guide 18:41 CDER Review Process 21:25 GCP Inspections 24:24 FDA’s GCP Inspection Process 26:17 CISST – Clinical Investigational Site Selection Tool 31:14 CI Inspections 32:34 Inspectio Compliance Classifications 35:59 Form FDA 483 & Response 37:00 Warining Letter 37:23 NIDPOE FDA Guideline - Processes and Practices Applicable to Bioresearch Monitoring Inspections 202406 https://www.fda.gov/media/179027/down... The FDA’s New Office of Inspections and Investigations -- What You Need To Know 112024 https://fda.complianceexpert.com/site... FDA Compliance Program CP-7348.809 IRB 20250404 https://www.fda.gov/media/75909/download FDA Compliance Program CP-7348.810 Sponsors and CROs 20210921 https://www.fda.gov/media/75916/download FDA Compliance Program CP-7348.811 Clinical Investigators 20200722 https://www.fda.gov/media/75927/download