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Materiovigilance Regulations


Eu2P Short Course: Materiovigilance Regulations

OBJECTIVES

This course aims to give you knowledge and understanding of the regulatory environment concerning medical devices.

Medical device, Field Safety Corrective Action, EU, US, MHRA

 

LEARNING OUTCOMES

At the end of this course, you will know and understand materiovigilance and all related current topics to materiovigilance such as:

  • the materiovigilance definition,

  • the medical device definition,

  • an incident definition,

  • European Union regulations,

  • the Field Safety Corrective Action definition,

  • the role of the Medical and Healtcare Product Regulatory Agency and the United States regulations.

 

60 minutes
Online based learning
English language
Certificate of Achievement
100 €
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AUTHORS

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Dr. Sherael Webley

University of Hertfordshire

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Leigh Gear

PV Compliance Director, Quality, Compliance and Audit (QCA)
Amgen NV




COMPANIES OFFER

Short courses can be included in a training package for your team!


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