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

					GlobalCompliancePanel                                                  Your Gateway to Regulatory Compliance

Live Webinar on

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

Date: Wednesday, March 20, 2013                                         Time: 10:00 AM PST | 01:00 PM EST

Duration: 60 Minutes             Location:   Online           Instructor: David Lim

Course "Global Medical Device Adverse Event Reporting
Systems in EU, Canada and US" has been pre-approved by RAPS as
eligible for up to 1.00 credits towards a participant's RAC recertification
                                                                                    Register Now
upon full completion.


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.


To achieve compliance and to remain compliant with the adverse event reporting requirements, it
is imperative that medical device manufacturers understand what requirements apply and how to
meet the said requirements.


Areas covered in the session:

    l   Applicable and relevant regulations in EU, Canada and US
    l   Definitions
    l   Medical device adverse event reporting requirements in EU, Canada and US
    l   Medical device vigilance system during the post-production phase in EU
    l   Mandatory medical device problem reporting requirements in Canada
    l   Mandatory medical device reporting requirements in US
    l   Review of actual reporting forms in EU, Canada and US
    l   Applicable and relevant guidance documents
    l   Conclusion



Who Will Benefit:                                         About Speaker

                                                          David Lim
    l   Regulatory Affairs
                                                          Chairman and CEO, Regulatory Doctor
        Managers, Directors and
        VPs
                                                          Dr. Lim obtained his Ph.D. in
    l   Clinical Affairs Managers,                        biological sciences at the University of
        Directors and VPs                                 Missouri-Columbia and published his
    l   Quality Managers, Directors                       thesis research in the prestigious
                                                          journal “Science.” Since then, Dr. Lim
        and VPs
                                                          has held various positions at Duke, US
    l   Quality Managers, Directors                       National Laboratories, Intrexon
        and VPs                                           Corporation, Terumo, US FDA/CDRH,
                                                          and EraGen Biosciences, Inc., A
    l   Compliance Managers and
                                                          Luminex Company. In 2009, Dr. Lim
        Directors                                         served as a member during the FDA’s
    l   Sales and Marketing                               Transparency Public Meeting. Prior to
        Managers, Directors, and                          founding his own consulting firm
                                                          (www.RegulatoryDoctor.com), Dr. Lim
        VPs
                                                          was Senior Vice President of Scientific
    l   Complaint Handling and                            and Regulatory Affairs at Aquavit
        Risk Management                                   Pharmaceuticals, Inc. in New York,
                                                          wherein Dr. Lim provided inspiring
        Managers and Directors
                                                          and actionable solutions for
    l   Site Managers, Directors,                         sustainable business operation. Dr.
        and Consultants                                   Lim as Regulatory Doctor provides
    l   Senior and Executive                              practical, actionable and strategic
                                                          solutions integrated with emotional
        Management                                        intelligence (EQ) skills for all aspects
    l   Compliance Officers and                           of global regulatory, quality, clinical
        Legal Counsel                                     and compliance matters. Over the
                                                          years, Dr. Lim has analyzed over
    l   Business Development
        Managers, Directors, and
                                                          1,000 FDA warning letters.   ...more
        VPs




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DOCUMENT INFO
Description: 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.