概要

This on-demand training course provides the foundational principles for medical devices and combination products. Insights into the US regulations and the European Medical Device Regulation (MDR) will be shared, as well as the practical implications for manufacturers and decision-makers. The course will also provide the pharmacovigilance and surveillance requirements for devices and combination products.

特集トピック

Introduction to medical devices in the US and EU
Introduction to combination products in the US and EU
Post-marketing and safety reporting in the US
Post-marketing reporting in the EU
cGMPs expectations for combination products in the US and EU

参加対象

This course is designed for professionals involved in:

Global medical safety
Regulatory affairs
Clinical affairs
Quality assurance
Safety and pharmacovigilance

学習目的

At the conclusion of this module, participants should be able to:

Differentiate between medical device regulations in the US and EU
Define key terminology used in medical devices and combination products
Identify key principles in pharmacovigilance for medical devices and combination products
Recognize the use of key global safety reporting documents

参加申し込み

Essentials of Medical Devices and Combination Products

概要

特集トピック

参加対象

学習目的

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