Webinar on Risk-Based Monitoring


On Tuesday, September 18, 2012, 12:00-13:00 (EDT), Dr. Jules T. Mitchel, President of Target Health will be presenting a Webinar on risk-based monitoring and eSource. To register, go to “Risky Business: Approaches to Monitoring Clinical Trials.”


The PERI Webinars are live instructor-led seminars on the Internet at a specific date and time. Every session includes a presentation followed by questions. The audio of the presentation is heard by calling the toll free number listed in the registration instructions. No special software is needed.


Objectives: The webinar will address the basic elements of the proposed regulations as well as the clinical data monitoring plan (CDMoP), the basic protocol elements when performing risk-based monitoring, how to interact with FDA to assure compliance with appropriate regulations, results of a Type C meeting with FDA that took place in July 2012 and how to implement change within companies.


Description: With the publication of the draft FDA Guidance on Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring and the draft EMA Reflection Paper on Risk- Based Quality Management in Clinical Trials, this webinar will investigate how the pharmaceutical and device industries are re-thinking and re-tooling their approaches to the monitoring of clinical trials.


Who Should Attend?: Those working in safety surveillance, regulatory affairs, product development, data management and computer systems who can benefit from knowledge of current regulatory developments in drug safety requirements as well as the strategies and processes applicable to safety surveillance.


For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com


Leave a Reply

You must be logged in to post a comment.