The presentation 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.
Live Webinar on Risk-Based Monitoring of Clinical Trials: Say Goodbye to 100% Source Document Verify Course "Efficient Risk-Based Monitoring of Clinical Trials: Say Goodbye to 100% Source Document Verify" has been pre- Register Now approved by RAPS as eligible for up to 1.00 credits towards a participant's RAC recertification upon full completion. Date & Time: Instructor Profile: Tuesday, May 29, 2012 10:00 AM PDT | 01:00 PM EDT Joy Frestedt Duration: 60 Minutes Instructor: Joy Frestedt President and CEO, Frestedt Incorporated Location: Online Price : $245.00 (for one participant) Joy Frestedt, PhD, CCTI, RAC, FRAPS. Dr. Frestedt is the President Overview: and CEO of Frestedt Incorporated, a The presentation reviews the long-awaited 'Guidance for Industry: novel virtual Contract Research Oversight of Clinical Investigations - A Risk-Based Approach to Organization network of over 50 Monitoring' which was released in August of 2011 to 'enhance human experts and highly skilled staff meeting specific needs in regulatory, subject protection and the quality of clinical trial data. clinical and quality affairs. Dr. Frestedt has over 30 years of This presentation will also review the information provided in the scientific, clinical and regulatory 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER experience in the health care, 48 - Bioresearch Monitoring' for foods, biologics, drugs and devices pharmaceutical and medical device (CPGM 7348.810 for sponsors, CROs and monitors and CPGM industries especially running clinical 7348.811 for clinical investigators and sponsor-investigators), as trials, conducting laboratory implemented in March, 2011. These documents are designed to analyses and assisting firms with strategic decisions involving clinical clearly articulate alternative practices for a "modern, risk-based research programs, regulatory approach" to monitoring, and attendees of this audio conference strategies and the development of gain valuable insight on the changes, and the resulting opportunity quality systems to compete globally. to change the way monitoring is done in efforts to improve attention She has held key positions including to human subject protection, high quality data and cost containment. vice president of scientific, regulatory and clinical affairs at BridgePoint Medical and Humanetics Corporation as well as key Why should you attend: management positions with Johnson LEARN WHAT TO CHANGE! This presentation reviews three FDA and Johnson’s Ortho Biotech, recent guidance documents about monitoring and discusses the Medtronic, Mayo Clinical Trial Services, AstraZenca changes needed in the industry to improve quality and manage Pharmaceuticals and Orphan costs. Medical. ...more Areas Covered in the Session: Suggest a Topic More Webinars l Three FDA documents will be reviewed about risk-based Your Necessity is our Priority monitoring, including a draft guidance for sponsors and two guidance documents for BIMO inspectors as they oversee the conduct of clinical studies l Key 'risk-based' approaches to monitoring l How to develop a monitoring plan, from the perspective of the inspector, sponsor, monitor, or coordinator Click here to register for this webinar Who Will Benefit: l Directors of Clinical Affairs l VPs & Directors of Regulatory Affairs l Manager of Quality Affairs l Clinical Research Coordinators & Associates l Research Nurses, Scientists and Others l Clinical Project Managers It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. 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