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Pharmacovigilance - Management of Periodic Safety Update Reports (PSURs) Course & Certification
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Pharmacovigilance - Management of Periodic Safety Update Reports (PSURs)
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About
The Management of Periodic Safety Update Reports (PSURs) Course & Certification is designed to provide a comprehensive understanding of the preparation, evaluation, and submission of PSURs in pharmacovigilance. The course focuses on ensuring continuous monitoring of medicinal product safety throughout their lifecycle in compliance with global regulatory requirements.
This course covers PSUR structure, data collection and analysis, benefit–risk evaluation, signal detection, regulatory submission requirements, and ICH E2C guidelines. It also emphasizes quality standards, documentation practices, and inspection readiness in pharmacovigilance reporting. Upon successful completion, learners receive a certification demonstrating competency in PSUR management.
Who Should Enrol ?:
- Pharmacovigilance Professionals
- Drug Safety and Risk Management Teams
- Medical Writers and Regulatory Writers
- Clinical Research Professionals
- Regulatory Affairs Professionals
- Quality Assurance and Compliance Teams
- Pharmaceutical and Biotechnology Employees
- Life Science, Pharmacy, Nursing, and Medical Graduates
What you will learn
Understand the fundamentals of Periodic Safety Update Reports (PSURs), including their purpose, regulatory importance, and role in ongoing pharmacovigilance.
Learn the structure and key content requirements of PSURs, including exposure data, significant findings, and safety information from reports and studies.
Gain knowledge of signal detection, benefit-risk evaluation, quality assurance, and submission processes involved in PSUR preparation.
Develop an understanding of regulatory assessment outcomes and the actions required to ensure continued product safety and compliance.
Course Syllabus
- Definition of PSURs
- Historical Background of PSURs
- Why Are PSURs Needed?
- Regulatory Drivers for PSURs
- EMA Regulatory Framework for PSURs
- ICH E2C(R2) & FDA Framework
- PSUR vs PBRER: Key Similarities and Differences
- Guiding Principles for Benefit-Risk Evaluation
- The Benefit-Risk Framework in PSURs
- Principles for Preparing PSURs
- Key PSUR Preparatory Considerations
- Contents of a PSUR — Overview
- PSUR Structure: All 18 Sections
- Introductory Information (Sections 1–3)
- The International Birth Date (IBD)
- Marketing Authorization Status (Section 3)
- Regulatory Actions & Reference Safety Information (Sections 4–5)
- Patient Exposure: Overview (Section 6)
- Exposure in Clinical Trials
- Exposure from Marketing Experience
- Cumulative Exposure Data
- Exposure in Special Populations
- Lesson 2 Summary: Format & Content Part 1
- Summary of Adverse Events (Section 7)
- Adverse Event Classification in PSURs
- Serious vs Non-Serious Adverse Events
- Clinical Trial Findings During the Reporting Interval (Section 8)
- Documenting Completed vs Ongoing Clinical Trials
- Findings from Non-Interventional Studies (Section 9)
- Post-Authorization Safety Studies (PASS) & Epidemiological Evidence
- Other Sources: Published Literature (Section 10)
- Registries, Databases & Other Data Sources
- Unpublished Data Sources in PSURs
- Lesson 3 Summary: Significant Findings from Reports and Studies
- Safety Signals: Definition & Types (Section 12)
- Signal Detection Methods
- Signal Validation & Assessment Process
- Risk Characterization (Section 13–14)
- Risk Factors & Vulnerable Patient Populations
- Risk Quantification Methods
- Benefit Evaluation (Section 15)
- Measuring Clinical Benefits
- Integrated Benefit-Risk Analysis (Section 15)
- Benefit-Risk Analysis Methods
- Integrated Benefit-Risk Summary — Example Effects Table
- PSUR Conclusion (Section 17)
- PSUR Appendices (Section 18)
- Lesson 4 Summary: Signals & Benefit-Risk Evaluation
- Quality Standards for PSUR Preparation
- Internal Review & Quality Control Process
- The Qualified Person for Pharmacovigilance (QPPV)
- Submission Frequency: EMA Requirements
- Submission Frequency: FDA Requirements
- The Data Lock Point (DLP)
- Special Submission Requirements
- Electronic Submission Standards
- Lesson 5 Summary: Quality Maintenance & Submission
- Regulatory Assessment Process Overview
- EMA Assessment Procedure: PRAC & CHMP
- Who Performs the PSUR Assessment?
- Risk Management Plan (RMP) Overview
- Risk Minimization Measures
- Product Modification Types Following PSUR Assessment
- SmPC, PIL & Labeling Changes
- Post-Marketing Surveillance & Ongoing Monitoring
- Lesson 6 Summary: Assessment of PSURs & Further Action
- 📘 Bonus: Management of Periodic Safety Update Reports (PSURs) eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
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.
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.
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.
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.
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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