We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.

These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.

This audio conference covers:

• An overview of three recent FDA guidance documents about risk-based monitoring, including guidance for sponsors as they train monitors and two guidance documents for BIMO inspectors as they oversee the conduct of clinical studies
• Key 'risk-based' approaches to monitoring
• How to develop a monitoring plan, from the perspective of the inspector, sponsor, monitor, or coordinator

About the speaker:

Joy Frestedt, PhD, RAC, CCTI is President & CEO of Frestedt Incorporated, a novel virtual network with 50 experts meeting client needs in regulatory, clinical and quality affairs. Dr. Frestedt has 30 years of scientific, clinical and regulatory experience in the health care, pharmaceutical, medical device and food industries including work at University of Minnesota, Mayo Clinical Trial Services, Johnson and Johnson, AstraZeneca, Orphan Medical, CNS Therapeutics, Medtronic and others. Dr. Frestedt holds a Ph.D. in pathobiology from the University of Minnesota Medical School and she is a member of ASCO, AAPS, ACRP and she currently Chairs the Ethics Committee for the Regulatory Affairs Professionals Society.

Who should attend?

• Directors of Clinical Affairs
• VPs & Directors of Regulatory Affairs
• Manager of Quality Affairs
• Clinical Research Coordinators & Associates
• Research Nurses, Scientists and Others
• Clinical Project Managers