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This content is a press release from our partner Business Wire. The AP newsroom and editorial departments were not involved in its creation.

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

February 22, 2019

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:

Agenda

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

Vigilance reporting

How to define and classify adverse events

Vigilance workshop

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/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

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

http://www.businesswire.com/news/home/20190222005203/en