The purpose of this session is to get you acquainted with adverse event reporting requirements and systems in EU, Canada and US. The obligation of Medical Device Manufacturers doesn’t end after obtaining a clearance, approval, registration, listings or certificates. They are required to report adverse events to the health authorities (e.g., Competent Authorities, Health Canada and US FDA) wherever applicable. To achieve compliance and remain compliant with adverse event reporting requirements, it is imperative that medical device manufacturers understand what requirements apply and how to meet those prescribed requirements.
In this conference, our presenter will walk you through the applicable adverse event reporting requirements and help you understand them clearly as well as explain how to remain in conformity with the requirements in EU, Canada and US. Going further with the session, Dr. Lim will help you change your way of planning, developing, implementing and following your relevant and applicable processes so that you do it efficiently and effectively. In this conference, you will be able to become familiar with Global Adverse Event Reporting (AER) systems and also ensure if your current AER system are compliant enough.
Areas Covered in the Session :
Applicable and relevant laws and regulations in EU, Canada and US
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
Common mistakes and how to prevent them
Who Will Benefit:
Research & Development
Anyone Interested in the FDA inspection Process