This presentation is intended to greatly help global medical device firms implement the global medical device adverse event (AER) reporting systems in EU, Canada, and US. Even if similar or relevant procedures have been implemented in your firms, it is time to ensure the relevant requirements are under check. To achieve compliance and remain compliant with the global adverse event reporting requirements, it is critical to accurately interpret and understand what requirements apply and how to meet the said requirements.
In this 60-min presentation, the speaker will guide you through the details of the required elements in implementing the global medical device adverse event reporting systems in EU, Canada and US.
- Applicable laws and regulations in EU, Canada, and US
- Guidance documents-relevant and applicable
- Adverse event reporting requirements in EU, Canada, and US
- Surveillance and vigilance systems in EU
- Mandatory medical device problem reporting requirements in Canada
- Mandatory medical device reporting (MDR) requirements in US
- Reporting template forms to review
- Speaker’s practical tips and cases
Dr David Lim,
President and Principal Consultant ,
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.
- Complaint Managers
- Regulatory Affairs
- Clinical Affairs
- R&D engineers and scientists, managers, directors, VPs
- Compliance and Legal Affairs
- Auditors and Consultants
- Senior Management
- Anyone Interested in Medical Device Complaint Handling Systems.