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FDA BIMO Courses

Safety Responsibilities for IRB Members Protecting Both Subjects and Staff

July 18, 2025

by VelSafe Staff Worker Safety

Safety Responsibilities for IRB Members: Protecting Both Subjects and Staff

Institutional Review Boards (IRBs) play a key role in research oversight. Their job goes far beyond reviewing study designs and consent forms. IRB members are responsible for protecting the rights, safety, and well-being of human subjects. But anothe

Quick Tips for Complying with In Vivo Bioequivalence Program Requirements

July 18, 2025

by VelSafe Staff Tips

Quick Tips for Complying with In Vivo Bioequivalence Program Requirements

Conducting in vivo bioequivalence (BE) studies is a critical step for companies developing generic drugs. These studies compare a test product to a reference drug to show that both perform the same in the human body. The U.S. Food and Drug Administra

How to Prepare for an FDA BIMO Inspection A Clinical Investigator’s Compliance Guide

July 18, 2025

by VelSafe Staff Guides

How to Prepare for an FDA BIMO Inspection: A Clinical Investigator’s Compliance Guide

When the FDA notifies you of a Bioresearch Monitoring (BIMO) inspection, it can feel overwhelming at first. These inspections are designed to review the quality and integrity of the clinical trial data submitted to the agency and to check whether inv