Maintaining Compliance of Clinical Sites with Regards to the FDA Draft Guidance on (Risk-Based Approach to Monitoring)
Course "Maintaining Compliance of Clinical Sites with Regards to the FDA Draft Guidance on (Risk-Based Approach to
Monitoring)" has been pre-approved by RAPS as eligible for up to 1.00 credits towards a participant's RAC recertification upon full completion.
Date & Time: Wednesday, July 18, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
Instructor: John A. McLane
Price : $245.00
John A. McLane Vice-President of Clinical and Regulatory Affairs, Clinquest Inc.
(for one participant)
Dr. McLane has over 25 years of progressive experience in all phases of global development with both large and small pharmaceutical companies. His knowledge basis has lead full development projects with over 50 clinical and medical device programs and to successful INDs, IDEs, NDAs and EMEA/CTA applications. Key strengths include the early development of clinical and regulatory strategies, risk management and identification, and negotiating with regulatory officials.
Why you should attend: The FDA is removing the old guidance document on monitoring and recommending changes that conflict with conventional Good Clinical Practices (GCP) that have been in place since the ICHE6 guidelines had been issued. What that means is more of the clinical team needs to be involved with monitoring the sites and the sites need to document compliance by additional means beyond source documentation. The routine monitoring of the sites would now goes beyond the CRA going to the site but also involves Project Managers, data management, statistics, medical monitoring, pharmacovigilance, and lab and IMP management. Sites need to know how the monitoring will change when and what they have to do (and when) to demonstrate compliance with the protocol, safety evaluations and assessments, data entry, and laboratory collection and assessments. Site-specific and study-specific documents such as Study Operations Manuals and monitoring plans should be changed to address the changes in monitoring. Project managers need metrics to assess when risk-based monitoring provides signals that could indicate changes in oversight may be needed to maintain data integrity and patient safety.
Areas Covered in the Session: l
Summary of guidance document: Oversight of Clinical Investigations-a Risk-based Approach to Monitoring Preplanning for high risk monitoring Roles of different clinical team members (e.g. project manager, clinical research associates, data management, biostatistics, clinical site coordinator, principle investigators, clinical trial associate)
Additional development activities include developing business rationale, teams, programs, and strategies for early clinical and combination product candidates in metabolic diseases, respiratory and oncology areas. He has also successfully completed in- and outlicensing reviews and negotiations including those for orphan indications and in vitro diagnostics. He possesses particular expertise in the initial formation and development of new start-ups and early clinical companies and has provided major contributions to business plans and presentations to venture capitalists for significant fund-raising. ...more
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Your Necessity is our Priority
Documentation (e.g. process and process maps, monitoring plans, monitoring reports, issue escalation)
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Who Will Benefit: l
Site Clinical Coordinators
Site Managers Clinical Operations Project Managers
l l l l l l l
Clinical Research Associates Clinical Trial Associates Medical Monitors Pharmacovigilance specialists Principle Investigators
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. Best regards, Event-coordinator GlobalCompliancePanel
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Published on Jun 20, 2012
The FDA is removing the old guidance document on monitoring and recommending changes that conflict with conventional Good Clinical Practices...