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.
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 Click here to register for this webinar Suggest a Topic More Webinars GlobalCompliancePanel www.globalcompliancepanel.com 43337 Livermore Common, Fremont CA 94539, USA. Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
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