Current Companion Diagnostic Regulatory Framework in the EU & US

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    Live Webinar           on
      Current Companion Diagnostic Regulatory Framework in the EU & US

     Course "Current Companion Diagnostic Regulatory Framework
     in the EU & US" has been pre-approved by RAPS as eligible for
                                                                                                  Register Now                          
     up to 1.00 credits towards a participant's RAC recertification
     upon full completion.

    Date & Time:                                                                            Instructor Profile:

     Wednesday, June 20, 2012            10:00 AM PDT | 01:00 PM EDT
                                                                                                        Sylvie Le Glédic 
     Duration: 60 Minutes                Instructor: Sylvie Le Glédic                                  Director IVD, Voisin
                                                                                                      Consulting Life Science
     Location: Online                    Price : $245.00   (for one participant)

                                                                                            Sylvie Le Glédic is Director, IVD's
                                                                                            – Medical devices at Voisin
     Overview:                                                                              Consulting Life Sciences (VCLS),
    This presentation will focus on the major regulatory issues that                        France. Sylvie Le Glédic brings over
    concerns diagnostic and pharmaceutical partners during co-                              two decades of experience in the
    development of a targeted therapeutic and companion diagnostic.                         regulatory field of in vitro diagnostic
                                                                                            (IVD) medical devices, including
                                                                                            biochemistry, haematology,
    This will include current development trends related to companion
                                                                                            immunology, blood gas and
    diagnostics, coordination of clinical trials, and the regulatory review                 molecular biology products, under
    of both products in the US and EU. After months of discussions on                       Annex II List A and List B.. At Voisin
    personalized medicine and the use of companion diagnostics with                         Consulting, she is in charge of the
    targeted therapeutics, the much anticipated draft FDA guidance                          design and implementation of global
    document on in vitro companion diagnostics was finally released by                      regulatory strategies for the
    the agency for comments. In contrast, the EU has yet to release any                     development of IVDs, and in
                                                                                            particular CDx in co-development
    specific guidance on companion diagnostic development and/or
                                                                                            with medicinal products. ...more
    finalize changes in the regulatory framework. We will discuss both
    the impact of the proposed draft guidance issued by the FDA and the
    expected major changes surrounding companion diagnostic
    regulation to occur in the EU.                                                         Suggest a Topic        More Webinars
                                                                                             Your Necessity is our Priority
     Why Should You Attend:
    This presentation will help the audience to understand the
    regulatory hurdles to be considered when developing a target
    therapeutic and a companion diagnostic. This audience will gain a
    clear perspective on how to shape their internal company practices                                         
    to be aligned with the latest thought process of regulators in both
    the US and EU.

     Areas Covered in the Session:

        l   Current trends in personalized medicine
        l   Coordination of clinical trials during co-development
        l   FDA draft guidance on CDx
        l   CDx/IVD regulatory framework and anticipated changes in EU
        l   Proposed interactions with the regulatory agencies
        l   Regulatory review process
        l   Case studies

    Click here to register for this webinar

     Who Will Benefit:

        l   Regulatory Affairs
        l   Business Development
        l   Top Management
        l   Research and Development
        l   Preclinical and Clinical Development

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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Description: This presentation will focus on the major regulatory issues that concerns diagnostic and pharmaceutical partners during codevelopment of a targeted therapeutic and companion diagnostic.