Medical Device Adverse Event Reporting in EU_ Canada and US

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					 Live Webinar on : Medical Device Adverse Event Reporting in EU, Canada and US
 Thursday, July 19, 2012 duration : 01:00 to 02:15 PM EDT

                                           Why should you attend :

                                           If you don’t know the answers to the following
                                           questions, you should attend the seminar:

                                           ·    What are the relevant and applicable laws and
                                           regulations governing medical device adverse event
                                           reporting in the EU, Canada and US?
Get 15 % Discount as a early bird
registrations. Use Promo Key :
 CGO15                                     ·    What adverse events are reportable in the EU,
                                           Canada and US?

                                           ·    What are the adverse event reporting
                                           requirements during clinical trials in the EU, Canada
                                           and US?

                                           ·           What are the adverse event reporting
                                           requirements during post-marketing?

                                           Webinar Includes:
                                           Q/A Session with the Expert to ask your question

                                           PDF print only copy of PowerPoint slides
Live ( Single registration ) : $189.00
Group ( Max 10 Attendee): $249.00          This webinar is intended to help you get familiar with
On Demand (Recording available):$289       the medical device adverse event reporting
Get Training CD : $449                     requirements during clinical studies and post-
Play back(Unlimited views):-309            marketing in the EU, Canada and US.
    Who will benefit                               The adverse event reporting is intended to improve
                                                   the patients’ safety and protection including the users
    Who will benefit: (Titles)                     and other stakeholders by preventing the repetitive
                                                   incidents or by reducing the harmful consequences of
    Regulatory        affairs     (associates,    the incidents.
    specialists, managers, and directors).
    Complaint managers                            Global compliance to the adverse event reporting
    Quality assurance, quality control, and       requirements is imperative to achieve sustainability
    quality systems (associates, specialists,      and to remain sustainable and competitive in global
    engineers, managers, directors and             medical device markets during both clinical trials and
    VPs).                                          post-marketing.
    Clinical affairs (associates, specialists,
    coordinators,      monitors,    managers,
    directors and VPs).
                                                   It is critical to understand the requirements, establish
    Research          and        development      and maintain a medical device adverse event reporting
    (associates,      scientists,   managers,      system. To do so, this webinar will present a practical
    directors and VPs).                            and actionable strategy to streamline the process by
    Product and development (associates,          employing a “CAC-SI” method.”
    scientists, managers, directors and
    Marketing      (associates,    specialists,
    managers, directors and VPs).
                                                   Areas Covered in the Session: 
    Site managers, and consultants.
    Contract manufacturing organization            Review the applicable statutes and regulations governing
    (associates,      scientists,   managers,      medical device adverse event reporting in the EU, Canada
    directors and VPs)                             and US
                                                     EU Directives and guidelines
                                                     GHTF guidance documents
                                                     EU risk management/ISO 14971
                                                     ISO 14155
                                                     Adverse event reporting requirements in EU
                                                     Mandatory medical device problem reporting in
                                                     Mandatory medical device reporting (MDR) in the US

                                                     Discuss speaker’s practical and actionable strategy
                                                   “CAC-SI” method.

                                                   About Speaker

                                                   Dr. David Lim obtained his Ph.D. in biological sciences at
                                                   the University of Missouri-Columbia and published his
                                                   thesis research in the prestigious journal “Science.” Since
                                                   then, he has held various positions at Duke, US National
                                                   Laboratories, Intrexon Corporation, Terumo, US
                                       FDA/CDRH, and EraGen Biosciences (A Luminex
                                       Company). In 2009, Dr. Lim served as a panel member
                                       during the FDA’s Transparency Public Meeting. Prior to
                                       founding his own consulting firm, Regulatory Doctor, Dr.
                                       Lim was Senior Vice President of Scientific and Regulatory
                                       Affairs at Aquavit Pharmaceuticals. Regulatory Doctor
                                       provides practical, actionable and strategic solutions
                                       integrated with emotional intelligence (EQ) skills for all
                                       aspects of global regulatory, quality, clinical and
                                       compliance matters. Dr. Lim has analyzed over 1,000 FDA
                                       warning letters, attended more than 50 FDA Advisory
                                       Panel Meetings, and analyzed the subject matters and
                                       decision-making processes in detail. He is familiar with
                                       more than 200 medical devices, IVD products, biologics,
                                       drugs and combination products. Dr. Lim is a certified
                                       professional for regulatory affairs (RAC) and also is a
                                       certified quality auditor (CQA) by the American Society
                                       for Quality (ASQ). He is an auditor, regulatory coach,
                                       consultant and instructor for global matters pertaining to
                                       regulatory affairs, regulatory compliance, quality and
                                       clinical affairs.
                      Compliance2go |
                      Phone : 877.782.4696 | Fax : 281-971-0286
                        Email :

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