is being presented by Dr. Joy Frestedt, Frestedt Incorporated and airs on Wednesday, February 29th, 2012. For more details, or to register please visit our site at www.fxconferences.com
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.
