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?
· 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?
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
75 Minutes Live Presentation
This webinar is intended to help you get familiar with the medical device adverse event reporting requirements during clinical studies and post-marketing in the EU, Canada and US.
The adverse event reporting is intended to improve the patients’ safety and protection including the users and other stakeholders by preventing the repetitive incidents or by reducing the harmful consequences of the incidents.
Global compliance to the adverse event reporting requirements is imperative to achieve sustainability and to remain sustainable and competitive in global medical device markets during both clinical trials and post-marketing.
It is critical to understand the requirements, establish and maintain a medical device adverse event reporting system. To do so, this webinar will present a practical and actionable strategy to streamline the process by employing a “CAC-SI” method.”
Areas Covered in the Session:
Review the applicable statutes and regulations governing medical device adverse event reporting in the EU, Canada and US
EU Directives and guidelines
GHTF guidance documents
EU risk management/ISO 14971
Adverse event reporting requirements in EU
Mandatory medical device problem reporting in Canada
Mandatory medical device reporting (MDR) in the US
Discuss speaker’s practical and actionable strategy “CAC-SI” method.
Who will benefit: (Titles)
· Regulatory affairs (associates, specialists, managers, and directors).
· Complaint managers
· Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs).
· Clinical affairs (associates, specialists, coordinators, monitors, managers, directors and VPs).
· Research and development (associates, scientists, managers, directors and VPs).
· Product and development (associates, scientists, managers, directors and VPs).
· Marketing (associates, specialists, managers, directors and VPs).
· Site managers, and consultants.
Contract manufacturing organization (associates, scientists, managers, directors and VPs)
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.
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