The Association of Clinical Research Professionals

Virtual ACRP 2020, Part I – Regulatory Trends & Compliance Track Replay

This package is a replay of the ACRP 2020 Virtual, Part 1 Program.  It includes the following sessions from the Regulatory Trends and Compliance Track:

  • Knock, Knock…FDA is Here AGAIN; Be Prepared for a Regulatory Inspection

What do you do when a regulatory agency knocks on the door? Turn off the lights? Panic? If you’re prepared, it should be an exercise to ensure your systems are working the way you designed them. Examine FDA Inspections and how to prepare for the inevitable knock, discuss available resources, and review responses received from 483s. Speaker: Eric Pittman, Program Division Director, FDA, Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs

  • FDA/ORA BIMO: Continuing Education and New Industry Metrics

Learn about the FDA BIMO Curriculum Committee and training initiatives, as well as existing BIMO industry metrics shared by FDA. Speaker: Eric Pittman, Program Division Director, FDA, Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs

  • The FDA’s CPGM BIMO: What You Need to Know As A Clinical Research Professional

The FDA uses the Compliance Program Guidance Manuals (CPGM) to direct its field personnel on the conduct of inspectional and investigational activities. The CPGM’s form the basis of FDA’s Bioresearch Monitoring Program. The purpose of each program is to ensure the protection of research subjects and the integrity of data submitted to the agency in support of a marketing application. In this session two of the CPGM BIMO documents will be discussed and address why every research professional should be familiar with the following documents: CPGM for Clinical Investigators; CPGM for Sponsors, Contract Research Organizations, and Monitors. Speaker: Elizabeth “Beth” Nelson, MPH, President and Senior Consultant, Regulatory Risk Management

  • CDER BIMO Compliance and Enforcement – What You Need to Know!

Explore key opportunities for the clinical research industry to make the FDA inspection experience a positive one.  Hear inspections’ impact on applications and identify key strategies to build quality into clinical research in order to prevent critical compliance issues. When problems do occur, inspected entities should be able to respond appropriately. Take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence. Speaker: David Burrow, Pharm.D., J.D. Director, Office of Scientific Investigations, Office of Compliance Center for Drug Evaluation and Research, FDA

  • Assessing Today’s Drug Development Operating Environment: Time to Hit the Reset Button?

[Note: Contact hours are not provided for this session.] This session examines major trends impacting the operating environment for new drug development including evolving pipelines, players and executional models.  The session will also explore the anticipated long term effects of global change and response to the coronavirus pandemic.  Speaker:  Kenneth A. Getz, Deputy Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine; Founder and Board Chair, CISCRP

Purchase Track Replay

This program is a compilation of recorded sessions from Virtual ACRP 2020, Part I.