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Plenary: Regulatory Research at FDA (2/14) REdI 2017
Regulatory and Administrative Components of an IND Application (5/14) REdI 2017
Overview of FDA's Expanded Access Program (13/14) REdI 2017
Overview of Non-clinical Assessment in Drug Development (8/14) REdI 2017
FDA GCP Inspection Trends found Using AI. Clinical Investigator Findings, 483s & Warning Letters
Overview of FDA Inspections
Routine Monitoring Visit: The investigator Site File Review
Walkthrough of a Pre-Approval Manufacturing Site Inspection (14of14) REdI 2018
Live Demo of the FDA Adverse Events Reporting System (14/14) REdI 2017
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Last Updated: October 3, 2026
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Summary
Faranak Jamali provides an overview of The YouTube video at the link provided, titled " Ksenia Blinova and Alexandre J. S. Ribeiro discuss Maureen Dillon-Parker provides an overview of the contents and format of the Investigational New Drug Application (IND), ... J. Paul Phillips provides an overview of the Hanan Ghantous covers the role and responsibilities of the pharmacology/toxicology reviewer related to the various components ... Sanjay K. Sahoo provides a live demonstration on how to use the dashboard. To increase transparency at Clinical investigations inspections This presentation described the purposes, focuses, and types of
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