Medical Device Adverse Event Reporting in EU, US and Canada

David Lim
Instructor David Lim
Product Id 600878
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Medical Device Adverse Event Reporting in EU, US and Canada

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. This webinar will walk you through to help you understand the applicable adverse event reporting requirements and remain in conformity with the requirements in EU, Canada and US.

This webinar will help you profoundly change your way of planning, developing, implementing and following your relevant and applicable processes in a more efficient and effective manner.

Why Should You Attend: 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 critical to accurately interpret and understand what requirements apply and how to meet the said requirements.

This webinar will walk you through to help you understand and stay in conformity with the adverse event reporting requirements in EU, Canada and US.


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

Who 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
Speaker Profile
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.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. Dr. Lim as 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. Over the years, Dr. Lim has analyzed over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 medical products (medical devices including 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). Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs and compliance, quality and clinical affairs.

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