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Understanding Periodic Safety Update Reports and how to submit your PSUR to BSI
Provides manufacturers with an understanding of BSI expectation in relation to PSURs and provide an overview of the recent guidance related to PSURs.
An understanding of BSI expectations in relation to PSUR.
An overview of MDCG 2022-25.
How to correctly submit PSURs to the notified body.
When to submit SSCPs alongside PSURs.
Head of Clinical Compliance, BSI
Regulatory Lead, BSI
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