Regulatory Open Forum

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  • 1.  Panel Opportunity

    Posted 16-Feb-2016 15:20


    I am organizing a regulatory panel for the World Biomaterials Congress, in Montreal, Canada, May 18-22, 2016.  The panel session, "Biomaterials & Medical Products Commercialization: Regulatory Case Studies – How to Get to Market?" is planned for Friday, May 20 at 4:30pm.

     

    My colleague and I are searching for interested regulatory professionals to sit on the panel discussion in the session.  The plan is to have several regulatory case studies that we'll explain, give multiple choice answers, have the audience vote, then have the panel explain the rationale for their choices.  The panel will get the questions several weeks in advance to prepare answers/talking points.  These case studies will introduce situations which many biomaterial developers face, including implementing quality systems, choosing biocompatibility testing, getting approval for First in Man studies, larger clinical trials, and bringing a product with a new material/feature to market.  There is no compensation for this panel, other than our gratitude and networking possibilities with the international biomaterials community. 

     

    Please let me know if you or anyone you know would be interested in participating in this international conference session. 

     

    Conference website:

    http://wbc2016.org/

     

     

     

    Julie Leslie, PhD

    Manager, Regulatory Affairs, Neuromodulation

    USA

     

    O +1 281 727 2672

    F +1 281 853 1292

     

    julie.leslie@livanova.com

    www.livanova.com

     

    Cyberonics

    100 Cyberonics Blvd

    Houston, TX 77058

     




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  • 2.  RE: Panel Opportunity

    Posted 17-Feb-2016 09:43

    Hi Julie,

    Are there any pre-requisites to be met by the panelists?

    Thanks.

    ------------------------------
    Sorin Alb
    Project Manager, Regulatory Affairs
    NUCRO TECHNICS
    Scarborough ON
    Canada