The Association of Clinical Research Professionals
Office of Regulatory Affairs (ORA) Update
This session will focus on an overview of the Office of Regulatory Affairs “Program Alignment” initiative including new divisions, what the initiative will mean for your next (or first) inspection, and who to contact with concerns. This session will also provide a review of current metrics associated with the Bioresearch Monitoring (BIMO) program, including common regulatory violations. Finally, recently released guidance documents and regulations changes related to good clinical practice will be discussed.