2-Day Seminar: Medical Device Studies - Regulatory Requirements and Adverse Event Reporting (London, United Kingdom - April 2-3, 2019) - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--Feb 22, 2019--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:
Topics covered include:
Programme Day One
Clinical evaluation - an overview
Clinical investigations - an overview
PMS and PMCF
Quiz on clinical evaluation, clinical investigation and PMCF
New requirements of the MDR
The Competent Authority and the Notified Body
Workshop on the new requirements of the MDR
Programme Day Two
Review of day one
How to define and classify adverse events
The regulatory requirements for monitoring and reporting adverse events during regulatory and PMCF studies
The MDR - clinical elements
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/
Laura Wood, Senior Press Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics:Medical Devices,Clinical Trials
KEYWORD: UNITED KINGDOM EUROPE
INDUSTRY KEYWORD: HEALTH MEDICAL DEVICES
SOURCE: Research and Markets
Copyright Business Wire 2019.
PUB: 02/22/2019 06:46 AM/DISC: 02/22/2019 06:46 AM