Medical Device Adverse Event Reporting Systems in EU, Canada and US - Webinar By GlobalCompliancePanel

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Medical Device Adverse Event Reporting Systems in EU, Canada and US - Webinar By GlobalCompliancePanel Powered By Docstoc
					                                                                                                                                       


    RAPS Approved Webinar                 on

     Medical Device Adverse Event Reporting Systems in EU, Canada and
     US

    Date & Time:                                                                                                                        

     Course "Medical Device Adverse Event Reporting Systems in
     EU, Canada and US" has been pre-approved by RAPS as eligible
                                                                                                 Register Now                           

     for up to 1.00 credits towards a participant's RAC recertification
     upon full completion.

                                                                                           Instructor Profile:

     Thursday, August 30, 2012          10:00 AM PDT | 01:00 PM EDT
                                                                                                           David Lim
     Duration: 60 Minutes               Instructor: David Lim                                          Chairman and CEO,
                                                                                                        Regulatory Doctor
     Location: Online                   Price : $245.00   (for one participant)

                                                                                           Dr. Lim obtained his Ph.D. in
                                                                                           biological sciences at the University
    Overview:                                                                              of Missouri-Columbia and published
    Medical device firms’ obligation doesn’t end upon obtaining a                          his thesis research in the prestigious
    marketing clearance, approval, or certificates. Medical device                         journal “Science.” Since then, Dr.
    manufacturers are required to report adverse events to the                             Lim has held various positions at
                                                                                           Duke, US National Laboratories,
    authorities (e.g., Competent Authorities, Health Canada and US
                                                                                           Intrexon Corporation, Terumo, US
    FDA), where applicable.
                                                                                           FDA/CDRH, and EraGen Biosciences,
                                                                                           Inc., A Luminex Company. In 2009,
    To achieve compliance and to remain compliant with the adverse                         Dr. Lim served as a member during
    event reporting requirements, it is imperative that medical device                     the FDA’s Transparency Public
    manufacturers understand what requirements apply and how to                            Meeting. Prior to founding his own
    meet the said requirements.                                                            consulting firm
                                                                                           (www.RegulatoryDoctor.com), Dr.
                                                                                           Lim was Senior Vice President of
    This webinar will walk you through to help you understand and stay
                                                                                           Scientific and Regulatory Affairs at
    in conformity with the adverse event reporting requirements in EU,
                                                                                           Aquavit Pharmaceuticals, Inc. in New
    Canada and US.                                                                         York, wherein Dr. Lim provided
                                                                                           inspiring and actionable solutions for
    This webinar will help you profoundly change your way of planning,                     sustainable business operation. Dr.
    developing, implementing and following your relevant and applicable                    Lim as Regulatory Doctor provides
    processes in a more efficient and effective manner.                                    practical, actionable and strategic
                                                                                           solutions integrated with emotional
                                                                                           intelligence (EQ) skills for all aspects
    Areas Covered in the Session:                                                          of global regulatory, quality, clinical
                                                                                           and compliance matters. Over the
                                                                                           years, Dr. Lim has analyzed over
       l   Applicable and relevant regulations in EU, Canada and US
                                                                                           1,000 FDA warning letters. Dr. Lim
       l   Definitions
                                                                                           has also attended more than 50 FDA
       l   Medical device adverse event reporting requirements in EU,                      Advisory Panel Meetings and
           Canada and US.                                                                  analyzed the subject matters and
       l   Medical device vigilance system during the post-production                      decision-making processes in detail.
           phase in EU.                                                                    Dr. Lim is familiar with more than
       l   Mandatory medical device problem reporting requirements in                      200 medical products (medical
                                                                                           devices including IVD products,
           Canada.
                                                                                           biologics, drugs and combination
       l   Mandatory medical device reporting requirements in US.
                                                                                           products). Dr. Lim is a certified
       l   Review of actual reporting forms in EU, Canada and US
                                                                                           professional for regulatory affairs
       l   Applicable and relevant guidance documents                                      (RAC) and also is a certified quality
       l   Conclusion                                                                      auditor (CQA) by the American
                                                                                           Society for Quality (ASQ). Dr. Lim is
    Click here to register for this webinar                                                an auditor, regulatory coach,
                                                                                           consultant and instructor for global
                                                                                           matters pertaining to regulatory
    Who Will Benefit:                                                                      affairs and compliance, quality and
                                                                                           clinical affairs. ...more

       l   Regulatory Affairs Managers, Directors and VPs
       l   Clinical Affairs Managers, Directors and VPs
       l   Quality Managers, Directors and VPs                                            Suggest a Topic        More Webinars
       l   Quality Managers, Directors and VPs
                                                                                            Your Necessity is our Priority
       l   Compliance Managers and Directors
       l   Sales and Marketing Managers, Directors, and VPs
       l   Complaint Handling and Risk Management Managers and
           Directors
       l   Site Managers, Directors, and Consultants
       l   Senior and Executive Management                                                                    
       l   Compliance Officers and Legal Counsel
       l   Business Development Managers, Directors, and VPs
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
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posted:7/25/2012
language:English
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Description: Overview: Medical device firms’ obligation doesn’t end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable.