2-Day Seminar: Medical Device Studies - Regulatory Requirements and Adverse Event Reporting (London, United Kingdom - April 2-3, 2019) - ResearchAndMarkets.com

The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting" conference has been added to ResearchAndMarkets.com's offering.

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting

This seminar provides an essential overview of medical device clinical evaluations, clinical investigations and post-market clinical follow-up (PMCF) studies with particular emphasis on the adverse event reporting requirements during these studies. The course will concentrate mostly on the new Medical Device Regulations (MDR) with some references to the existing Medical Device Directives.

It will provide a good introduction to medical device clinical studies and serve as an update for those with experience who need to keep abreast of the regulatory changes and the methods of handling adverse events during the study period. It also covers the new requirements regarding periodic safety update reports (PSURs) and the summary of safety and clinical performance.

By attending this meeting you will:

• HEAR all you need to know about the regulatory requirements for monitoring and reporting adverse events in one information packed day
• FIND OUT when a clinical investigation is need
• DISCOVER the requirements for vigilance reporting
• UNDERSTAND the main changes involved with the new Medical Device Regulations
• APPRECIATE the role of The Competent Authority and how to, when to, and what to communicate with the authority

Topics covered include:

• The regulatory requirements for monitoring and reporting adverse events during medical device studies
• How to define and classify adverse events
• Clinical investigations and evaluations
• PMS and post-market clinical follow-up studies
• Vigilance reporting
• The role of the Competent Authority

Agenda

Programme Day One

Clinical evaluation - an overview

• What is a clinical evaluation?
• How do you conduct a clinical evaluation?
• The regulatory requirements pertaining to clinical evaluation

Clinical investigations - an overview

• What is a clinical investigation?
• When are clinical investigations needed?
• The regulatory requirements

PMS and PMCF

• What is PMS?
• What is PMCF?
• When are PMCF studies necessary?

Quiz on clinical evaluation, clinical investigation and PMCF

New requirements of the MDR

• Summary of safety and clinical performance
• Periodic safety update report (PSUR)

The Competent Authority and the Notified Body

• What is their role in the above processes?
• What are the responsibilities of the manufacturer?
• What to communicate and when

Workshop on the new requirements of the MDR

Programme Day Two

Review of day one

Vigilance reporting

• What is vigilance?
• The requirements for vigilance reporting during medical device studies

How to define and classify adverse events

• Definitions
• Types of events
• Determining categories

Vigilance workshop

The regulatory requirements for monitoring and reporting adverse events during regulatory and PMCF studies

• MEDDEV guidance document
• ISO 14155 harmonised standard
• Responsibilities
• Templates

The MDR - clinical elements

• Focus on changes in the clinical arena
• Chapter 6: clinical evaluation and investigation
• Annex 14: clinical evaluation and post-market clinical follow-up

Discussion session and end of seminar

For more information about this conference visit https://www.researchandmarkets.com/research/lmczjn/2day_seminar?w=4

View source version on businesswire.com: https://www.businesswire.com/news/home/20190222005203/en/