A Kaplan EduNeering course

This is the first in a series of courses that provide an overview of FDA’s Bioresearch Monitoring (BIMO) program and the methods and techniques used in conducting and reporting Nonclinical Laboratory, Clinical Investigator, Institutional Review Board (IRB), Sponsor/Monitor, and in vivo Bioequivalence Inspections.  This course provides an overview and historical perspective of FDA’s BIMO program

Topics include:
      ·          Evolution of FDA’s regulatory history
      ·          BIMO terminology
      ·          The purpose of FDA’s BIMO program
      ·          Regulations and expectations that are part of FDA’s BIMO program
      ·          How FDA implements the clinical BIMO program

Linda Belmont at DIA