March 2, 2020 @ 2:00 PM – 3:00 PM
LIVE Online Seminar (LIVE Webinar)

LIVE Seminar Online

Implementing Global Medical Device Adverse Event Reporting (AER) Systems in EU, Canada and US

  • Date: September 9, 2019
  • NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Mondays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 11:00 AM PST | 02:00 PM EST
  • Duration: 60 Minutes


About the Seminar

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.

About the Areas to Be Discussed

  1. Applicable laws and regulations in EU, Canada, and US
  2. Definitions
  3. Guidance documents-relevant and applicable
  4. Adverse event reporting requirements in EU, Canada, and US
  5. Surveillance and vigilance systems in EU
  6. Mandatory medical device problem reporting requirements in Canada
  7. Mandatory medical device reporting (MDR) requirements in US
  8. Reporting template forms to review
  9. Speaker’s practical tips and cases

About the Intended Attendee(s)

  • Complaint Managers
  • Regulatory Affairs
  • Quality
  • Clinical Affairs
  • R&D engineers and scientists, managers, directors, VPs
  • Compliance and Legal Affairs
  • CRO
  • Auditors and Consultants
  • Senior Management
  • Anyone Interested in Medical Device Complaint Handling Systems

About the Seminar Speaker

David Lim Photo.JPGDr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules, guidance, and regulatory requirements applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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. Dr. Lim serves as a member of the Advisory Board for Inspection Insider published by the FDA News. Dr. Lim also contributes to FDA Doctor and FDA Guidance Net.

Registration Options

LIVE (one attendee): $199 


LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Implementing Global Medical Device Adverse Event Reporting Systems