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About

An introduction to the management of Periodic Safety Update Reports (PSURs) in pharmacovigilance, focusing on the systematic evaluation of a medicinal product’s benefit–risk balance throughout its lifecycle. Covers PSUR preparation, data collection from global sources, signal detection inputs, and integration of safety findings from clinical trials and post-marketing data. Highlights regulatory requirements under ICH E2C(R2), EMA guidelines, and other global authorities, along with the roles of DSUR/PSUR/ PBRER formats. Also introduces the structure of PSURs, including cumulative exposure, safety signal evaluation, benefit–risk assessment, and conclusions with recommended actions for risk minimisation and regulatory compliance.An introduction to the management of Periodic Safety Update Reports (PSURs) in pharmacovigilance, focusing on periodic evaluation of a medicine’s benefit–risk balance throughout its lifecycle. Covers PSUR preparation, global data collection, and integration of safety information from clinical trials and post-marketing sources. Highlights key regulatory requirements under ICH E2C(R2), EMA, and other authorities, along with PSUR/PBRER structure, including safety signal review, benefit–risk assessment, and regulatory compliance considerations.

This course provides an overview of the end-to-end management of Periodic Safety Update Reports (PSURs), including planning, preparation, and regulatory submission. It covers evaluation of global safety data, benefit–risk assessment, and PSUR/PBRER structure. It also highlights key regulatory requirements (ICH E2C(R2), EMA) along with quality review and compliance best practices.

Course Syllabus

  1. Definition of PSURs
  2. Historical Background of PSURs
  3. Why Are PSURs Needed?
  4. Regulatory Drivers for PSURs
  5. EMA Regulatory Framework for PSURs
  6. ICH E2C(R2) & FDA Framework
  7. PSUR vs PBRER: Key Similarities and Differences
  8. Guiding Principles for Benefit-Risk Evaluation
  9. The Benefit-Risk Framework in PSURs
  10. Principles for Preparing PSURs
  11. Key PSUR Preparatory Considerations
  12. Contents of a PSUR — Overview
  13. PSUR Structure: All 18 Sections

  1. Introductory Information (Sections 1–3)
  2. The International Birth Date (IBD)
  3. Marketing Authorization Status (Section 3)
  4. Regulatory Actions & Reference Safety Information (Sections 4–5)
  5. Patient Exposure: Overview (Section 6)
  6. Exposure in Clinical Trials
  7. Exposure from Marketing Experience
  8. Cumulative Exposure Data
  9. Exposure in Special Populations
  10. Lesson 2 Summary: Format & Content Part 1

  1. Summary of Adverse Events (Section 7)
  2. Adverse Event Classification in PSURs
  3. Serious vs Non-Serious Adverse Events
  4. Clinical Trial Findings During the Reporting Interval (Section 8)
  5. Documenting Completed vs Ongoing Clinical Trials
  6. Findings from Non-Interventional Studies (Section 9)
  7. Post-Authorization Safety Studies (PASS) & Epidemiological Evidence
  8. Other Sources: Published Literature (Section 10)
  9. Registries, Databases & Other Data Sources
  10. Unpublished Data Sources in PSURs
  11. Lesson 3 Summary: Significant Findings from Reports and Studies

  1. Safety Signals: Definition & Types (Section 12)
  2. Signal Detection Methods
  3. Signal Validation & Assessment Process
  4. Risk Characterization (Section 13–14)
  5. Risk Factors & Vulnerable Patient Populations
  6. Risk Quantification Methods
  7. Benefit Evaluation (Section 15)
  8. Measuring Clinical Benefits
  9. Integrated Benefit-Risk Analysis (Section 15)
  10. Benefit-Risk Analysis Methods
  11. Integrated Benefit-Risk Summary — Example Effects Table
  12. PSUR Conclusion (Section 17)
  13. PSUR Appendices (Section 18)
  14. Lesson 4 Summary: Signals & Benefit-Risk Evaluation

  1. Quality Standards for PSUR Preparation
  2. Internal Review & Quality Control Process
  3. The Qualified Person for Pharmacovigilance (QPPV)
  4. Submission Frequency: EMA Requirements
  5. Submission Frequency: FDA Requirements
  6. The Data Lock Point (DLP)
  7. Special Submission Requirements
  8. Electronic Submission Standards
  9. Lesson 5 Summary: Quality Maintenance & Submission

  1. Regulatory Assessment Process Overview
  2. EMA Assessment Procedure: PRAC & CHMP
  3. Who Performs the PSUR Assessment?
  4. Risk Management Plan (RMP) Overview
  5. Risk Minimization Measures
  6. Product Modification Types Following PSUR Assessment
  7. SmPC, PIL & Labeling Changes
  8. Post-Marketing Surveillance & Ongoing Monitoring
  9. Lesson 6 Summary: Assessment of PSURs & Further Action

Course Benefits

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Fully compliant

This course describes the compliance requirements for the reporting of adverse events relating to medical devices. Learners also receive 4 Continual Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.

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Certified

All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam doesn’t mean taking the same questions again and again.

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Affordable

Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.

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Time-saving

Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training. Our reporting tools make it easy for administrators to check the progress of learners and identify areas for future training.

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Reliable and trustworthy

This course was written by Steve Jolley, a recognised expert in International drug and device vigilance. You will stay up to date with any international legislative changes in device vigilance as our training courses are constantly monitored, reviewed and updated (last updated in May 2018). Steve Jolley is a Cambridge University graduate with 25 years’ experience in drug & device safety & vigilance, who specializes in global safety compliance, business process improvement and signal detection. He is the Chairperson of the DIA Clinical Safety and Pharmacovigilance steering committee for North America and has worked with over 80 clients in the US, Europe and Japan. He is a featured speaker with the FDA and MHRA at DIA conferences and webinars on drug safety topics including auditing and signaling.)


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