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Live Webinar


Maintaining Compliance of Clinical Sites with Regards to the FDA Draft Guidance on (Risk-Based Approach to Monitoring)

Course "Maintaining Compliance of Clinical Sites with Regards to the FDA Draft Guidance on (Risk-Based Approach to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.


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Instructor Profile:

Date & Time: Wednesday, July 18, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: John A. McLane

Location: Online

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

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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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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

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

Maintaining Compliance of Clinical Sites with Regards to the FDA Draft Guidance  

The FDA is removing the old guidance document on monitoring and recommending changes that conflict with conventional Good Clinical Practices...

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