Pharmaceutical Filings & Registration Procedures in the EU - Webinar By GlobalCompliancePanel by globalcompliancepane


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    RAPS Approved Webinar                  on
      Pharmaceutical Filings & Registration Procedures in the EU

    Date & Time:                                                                                                                      

     Course "Pharmaceutical Filings & Registration Procedures 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:

     Wednesday, August 22, 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 : $295.00   (for one participant)

                                                                                            For the past 9 years, Bob has been
                                                                                            President of RJR Consulting, Inc. The
     Overview:                                                                              company assists the pharmaceutical,
    This session covers the various licensing methods (for Drugs,                           medical device and biotech
    Biologics & Combination Products) by which applicants can file for                      industries in understanding and
    product licenses (Marketing Authorizations) in one or multiple                          complying with International
                                                                                            Regulations affecting compliance,
    Member States, as well as fully across all Member States of the
                                                                                            new product development,
    European Union.
                                                                                            manufacturing and quality
                                                                                            assurance. RJR has offices in
    This course specifically outlines and discusses the structure of the                    Columbus, OH, Washington, DC,
    regulatory agencies at the EU-level and across specific Member                          Brussels, Belgium with exclusive
    States. Course content will explain which procedures are available                      affiliates across Asia and Latin
    for which products and then will follow the license processing steps                    America. Bob has 28 years of past
    for each pathway.                                                                       industry experience as a CMC
                                                                                            specialist, R&D Director and Global
                                                                                            Director of Regulatory Affairs for
    Product examples will be discussed to illustrate effective filing
                                                                                            Merion Merrill Dow pharmaceuticals
    techniques and when Full vs. Abridged applications will be required.                    and Cordis-Dow medical devices. He
    The Course will link the requirements of the EU Clinical Trial Directive                has a BS / MS degree in Chemistry.
    and discuss when existing clinical data might be sufficient to file.                    ...more
    Related ICH compliant requirements such as GCP and GMP will enter
    the licensing approval process. Common issues that have caused
    difficulties for pharmaceutical firms will be discussed.  Course content               Suggest a Topic       More Webinars
    will explain how the EU interacts with national regulatory agencies
    and how companies can best address the conflicts that sometimes                          Your Necessity is our Priority

     Areas Covered in the Session:

        l   EU Agency Regulatory Structure
        l   Registration Options
        l   Company Strategy- Linking Clinical Trials & Marketing
            Authorization Applications
        l   Balancing Strategy and Regulatory Cost/Maintenance
        l   2007 Pediatric Legislation Overview
        l   IMP Dossier- EU Expectations and Comparison of CTA to IND
        l   Registration Procedures
                ¡ Mutual Recognition vs. Centralized Procedure
        l   Abridged Applications
        l   Variations
                ¡ Labeling & Packaging Leaflet Requirements
        l   Changes to Marketed Products
        l   Maintaining Your License: Renewals
        l   Decision Making Process
        l   Review of Regulatory Authorities
               ¡ International, Regional, and Local laws applicable for the

                   European Union
        l   Member State Analysis of Applicable Regulations
        l   Political Implications of the Regulations
               ¡ Compare/Contrast EMEA and the FDA procedures
        l   How and When to Influence the Regulatory Process
        l   Using Regulations / Regulatory Contacts to Your Advantage

    Click here to register for this webinar

     Who Will Benefit:
     l   Regulatory personnel
     l   Administrative staff
     l   Compliance Professionals
     l   Sales or general management
     l   Clinical Research Professionals

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,

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
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giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs.
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