Risk-Based Monitoring of Clinical Trials: Say Goodbye to 100% Source Document Verify by globalcompliancepane


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    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
     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
                                                                                              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.

Best regards,

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