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Follow on Google News | Medical Device Adverse Event Reporting Systems in EU, Canada and US from GlobalCompliancePanel“Medical Device Adverse Event Reporting Systems in EU, Canada and US” is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on March 6.
Once a medical device manufacturer has obtained license and other necessary permits and certificates, an important part of his obligations starts. The manufacturer has to report Adverse Events (AE) to the designated authorities. These are the Competent Authorities in different countries of the EU; Health Canada and the US FDA. Manufacturers need to have a thorough and proper understanding of the steps required for AE reporting. They should have a good grasp of the details of the provisions of the Directives set out in these documents, and more importantly, should know how to interpret them. This webinar does just that –making participants familiar with the Directives, as well as making them understand how to interpret and apply them using their judgment and discretion. Following this training session, participants will have a much deeper and broader understanding of how to report AE’s to the authorities, and thus stay in line with both compliance and business requirements. ------------------------------------------------------------ When: Wednesday, March 6, 2013 ------------------------------------------------------------ By whom: Dr. David Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ).Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal,Science. Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs and compliance, quality and clinical affairs.He is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). In 2009, Dr. Lim served as a member during the FDA’s Transparency Public Meeting. Over the years, he has analyzed over 1,000 FDA warning letters. He has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. ------------------------------------------------------------ For whom: The webinar will benefit Regulatory Affairs Managers, Directors and VPs Clinical Affairs Managers, Directors and VPs Quality Managers, Directors and VPs Quality Managers, Directors and VPs Compliance Managers and Directors Sales and Marketing Managers, Directors, and VPs Complaint Handling and Risk Management Managers and Directors Site Managers, Directors, and Consultants Senior and Executive Management Compliance Officers and Legal Counsel Business Development Managers, Directors, and VPs ------------------------------------------------------------ Duration: 60 minutes ------------------------------------------------------------ To enroll for this webinar, contact webinars@globalcompliancepanel.com Phone: 800-447-9407 End
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