Course Area
Availability
Available for 90 days after enrollment
Approximate Course Run Time
1 hour
Continuing Education Units
0.1
Course Fee
No charge
E-learning content is available on demand
Course Details
Understanding Periodic Safety Update Reports
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.
Understanding Periodic Safety Update Reports and submitting to BSI
Manufacturers will understand BSI's expectation in relation to PSURs and provide an overview of the recent guidance related to PSURs (MDCG 2022-21).
Speakers
- Richard Holborow, Head of Clinical Compliance, BSI
- Maddalena Pinsi, Regulatory Lead, BSI
