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The European Clinical Trial Directive (EUCTD) - Webinar By GlobalCompliancePanel

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The European Clinical Trial Directive (EUCTD) - Webinar By GlobalCompliancePanel Powered By Docstoc
					                                                                                                                                      


    RAPS Approved Webinar                  on
 
     The European Clinical Trial Directive (EUCTD)

    Date & Time:                                                                                                                       

     Course "The European Clinical Trial Directive (EUCTD)" has
     been pre-approved by RAPS as eligible for up to 1.5 credits
                                                                                                  Register Now                         

     towards a participant's RAC recertification upon full completion.


                                                                                             Instructor Profile:
     Wednesday, July 18, 2012             10:00 AM PDT | 01:00 PM EDT

     Duration: 90 Minutes                 Instructor: Robert J. Russell                                  Robert J. Russell
                                                                                                     President, RJR Consulting,
     Location: Online                     Price : $245.00   (for one participant)
                                                                                                                Inc.


                                                                                             For the past 9 years, Bob has been
    Overview:
                                                                                             President of RJR Consulting, Inc. The
    This course covers the requirements for conducting Clinical Studies                      company assists the pharmaceutical,
    across the EU via the requirements of the EU Clinical Trial Directive                    medical device and biotech
    for Drugs, Biologics & Combination Products.                                             industries in understanding and
                                                                                             complying with International
                                                                                             Regulations affecting compliance,
    The course also covers recent updates on EU GCP associated with
                                                                                             new product development,
    the Directive, the highlights of the new EU Pharmacovigilance
                                                                                             manufacturing and quality
    Directive, as it relates to studies and helpful tips into working with                   assurance. RJR has offices in
    the European regulators. Additionally, changes to the Clinical Trial                     Columbus, OH, Washington, DC,
    Directive are being contemplated and the Course Director will provide                    Brussels, Belgium with exclusive
    insight into those areas, which may receive modification.                                affiliates across Asia and Latin
                                                                                             America. Bob has 28 years of past
                                                                                             industry experience as a CMC
    Areas Covered in the Session:                                                            specialist, R&D Director and Global
                                                                                             Director of Regulatory Affairs for
                                                                                             Merion Merrill Dow pharmaceuticals
       l   Overview of the EU and the EU Regulatory Structure
                                                                                             and Cordis-Dow medical devices. He
       l   Marketing Authorization Options in the EU
                                                                                             has a BS / MS degree in Chemistry.
       l   Overview of the European Union Clinical Trial Directive
                                                                                             ...more
       l   2007 Pediatric Legislation
       l   Processes and Timelines
       l   The Ethics Committee
                                                                                            Suggest a Topic       More Webinars
       l   Phases of a Clinical Trial
       l   Trial Protocol and Project Management
                                                                                              Your Necessity is our Priority
       l   Investigational Medicinal Product Dossier
       l   Standard Operating Procedures
       l   Clinical Trial Authorization Application
       l   Good Clinical Practice
       l   Good Manufacturing Practice
                                                                                                               
       l   Pharmacovigilance
       l   Handling the end of Clinical Trial
       l   Clinical Trial Databases
       l   European Union vs. The United States
       l   Regulatory Process in the EU
       l   Recent updates to the Directive


    Click here to register for this webinar


    Who Will Benefit:


       l   Clinical Operations Staff
       l   Project Team Members
       l   Quality Assurance, Monitors, CRAs
       l   Regulatory Affairs
       l   Investigators & Site Study Staff
       l   Clinical Trial Supply
       l   CROs, Consultants, Insurers



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
www.globalcompliancepanel.com
1000 N West Street Suite,
1200 Wilmington DE 19801

Phone: 800-447-9407 or
Fax your PO to: 302-288-6884


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DOCUMENT INFO
Description: Overview: This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive for Drugs, Biologics & Combination Products. The course also covers recent updates on EU GCP associated with the Directive, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. Additionally, changes to the Clinical Trial Directive are being contemplated and the Course Director will provide insight into those areas, which may receive modification.