Changes to Good Pharmacovigilance Practices in the EU - Webinar By GlobalCompliancePanel by globalcompliancepane


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    RAPS Approved Webinar                  on
     Changes to Good Pharmacovigilance Practices in the EU

    Date & Time:                                                                                                                       

     Course "Changes to Good Pharmacovigilance Practices in the
     EU" has been pre-approved by RAPS as eligible for up to 1.5
                                                                                                  Register Now                         

     credits towards a participant's RAC recertification upon full

                                                                                             Instructor Profile:

     Tuesday, August 14, 2012             10:00 AM PDT | 01:00 PM EDT
                                                                                                         Robert J. Russell
     Duration: 90 Minutes                 Instructor: Robert J. Russell                              President, RJR Consulting,
     Location: Online                     Price : $245.00   (for one participant)

                                                                                             Robert J. Russell, For the past 9
                                                                                             years, Bob has been President of
    Overview:                                                                                RJR Consulting, Inc. The company
    New Legislation & Guidance for Pharmacovigilance will apply in the                       assists the pharmaceutical, medical
    European Union (EU) beginning July 2012. To assist in its                                device and biotech industries in
    implementation with sponsors, applicants and license holders, a                          understanding and complying with
                                                                                             International Regulations affecting
    series of Guidance Documents is being written, which will replace the
                                                                                             compliance, new product
    current set of Volume 9A of the Rules Governing Medicinal Products in
                                                                                             development, manufacturing and
    the EU. The legal framework for pharmacovigilance on Medicinal                           quality assurance. RJR has offices in
    Products for Human Use has now been updated, through an                                  Columbus, OH, Washington, DC,
    amended EU Regulation (No 1235/2010) and Directive (2010/84/EC).                         Brussels, Belgium with exclusive
                                                                                             affiliates across Asia and Latin
                                                                                             America. Bob has 28 years of past
    Areas Covered in the Session:                                                            industry experience as a CMC
                                                                                             specialist, R&D Director and Global
       l   Pharmacovigilance systems                                                         Director of Regulatory Affairs for
                                                                                             Merion Merrill Dow pharmaceuticals
       l   Reporting and Management of Adverse Reactions
                                                                                             and Cordis-Dow medical devices. He
       l   Periodic Safety Update Reports
                                                                                             has a BS / MS degree in Chemistry.
       l   Post Authorization Safety Studies
       l   Changes to Definitions
       l   The Pharmacovigilance Risk Assessment Committee

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    Who Will Benefit:

       l   Senior Management
       l   Project Managers
       l   Clinical Trial Heads                                                                                
       l   PV Reporting
       l   Medical Writers
       l   Project Managers
       l   CRAs and CRCs
       l   QA / Compliance personnel
       l   Investigators
       l   Clinical Research Scientists
       l   QA / QC Auditors and Staff
       l   Consultants

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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