Module 16 2022

9/2/2022

Lecture 6: Understanding of the Periodic Safety Update Report (PSUR) under the MDR

Presented by:

Adrian Keene, Senior Director, Global Biological Safety and Validation and EMEA Consulting Services

Date:

September 2022

© NAMSA 2021

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Questions

• What are PSUR’s and what makes them different from regular PMS reports? • How to define, gather, record and analyse relevant inputs for PSURs in accordance to your Quality Management System? • What is done with the PSUR reports, after they have been prepared and internally reviewed? • What are the relevant stakeholders doing with the information that is contained within the PSUR?

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© NAMSA 2021

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