概要

The EU’s 2017 passage of new medical device regulations presents substantial changes in how clinical trials of medical devices are disclosed in the EU, from protocol approval to the reporting of summary results. In 2020, Eudamed will provide the public with a comprehensive view of medical device research and approvals throughout the EU. This webinar will look at the new EU requirements and discuss how sponsors can approach meeting them.

特集トピック

Brief background of medical device regulations
Overview of Regulation (EU) 2017/145
Planning your approach to Eudamed

参加対象

Professionals who work in the area of:

Compliance
Clinical trial disclosure
Transparency policies and compliance
Clinical operations
Medical writing, medical affairs, and medical communications
Regulatory
Publications
Biometrics
Data management
Disclosure
Data transparency/data sharing

学習目的

At the conclusion of this content preview webinar, participants should be able to:

Discuss the updates in EU medical device regulations including Regulation 2017/145 and the creation of Eudamed
Understand the effect Eudamed will have on disclosure requirements for trial results, while helping increase transparency of results for patients
Identify strategies to remain compliant with EU regulations and prepare submissions for Eudamed

Continuing Education Credits are not available for this event.

On Demand Content Preview Webinar: EU Device Regulations – The European Database on Medical Devices (Eudamed)

概要

特集トピック

参加対象

学習目的

最新情報や機会を逃さないで