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About

An introduction to the principles of periodic benefit-risk evaluation and regulatory reporting for pharmaceutical products across global markets. The course focuses on ICH E2C(R2) guidelines and their implementation by major regulatory authorities such as FDA, EMA, PMDA, and Health Canada. It covers key concepts including benefit-risk integration, reporting timelines, and structured PBRER preparation. Designed to provide a clear understanding of global pharmacovigilance reporting standards.

The PBRER course provides a comprehensive understanding of periodic benefit-risk reporting, including its structure, content, and regulatory expectations. It covers key components such as exposure data, safety tabulations, signal management, and benefit evaluation. The course also explains integrated benefit-risk analysis and regulatory decision-making processes. Emphasis is placed on practical writing, data interpretation, and maintaining compliance with global guidelines. This module builds a strong foundation in PBRER medical writing and pharmacovigilance practices.

Course Syllabus

  1. What Is a PBRER?
  2. The Transition from PSUR to PBRER
  3. PSUR vs. PBRER: Key Differences
  4. ICH E2C(R2) Guideline: The Foundation
  5. Global Regulatory Framework for PBRER
  6. The International Birth Date (IBD): Timing PBRER Cycles
  7. Data Lock Point (DLP): Practical Considerations
  8. Stakeholder Responsibilities in PBRER Production
  9. The PBRER Multidisciplinary Team
  10. PBRER Reporting Schedule and Timelines
  11. PBRER vs. DSUR: Complementary Documents
  12. Clinical Trial Registries and PBRER

  1. The 20 Mandatory Sections of the PBRER
  2. The Modular Structure: Design and Purpose
  3. Reference Safety Information (RSI) and CCSI
  4. The 'Listedness' Concept: Listed vs. Unlisted ADRs
  5. MedDRA: Mandatory Terminology for Safety Data
  6. Technical Standards: FHIR and Modern Data Interchange
  7. PBRER-DSUR Content Sharing Framework
  8. Technical Format Requirements for PBRER Submission
  9. Fixed-Dose Combinations (FDCs): Special Considerations

  1. Sections 1–4: Regulatory Foundations
  2. Writing Section 1: Introduction
  3. Writing Section 2: Worldwide Marketing Authorization Status
  4. Section 5: Estimated Exposure and Use Patterns
  5. Exposure Calculation Methods: Post-Marketing
  6. Section 6: Data in Summary Tabulations
  7. Sections 7–14: Synthesizing Global Evidence
  8. Writing Section 7: Clinical Trial Summaries
  9. Sections 8 & 9: Non-interventional and Other Trials
  10. Sections 10 & 11: Non-clinical Data and Literature
  11. Sections 12 & 14: Other Reports and Late-Breaking Information
  12. Section 13: Lack of Efficacy in Controlled Clinical Trials
  13. Signal Management: The PBRER's Analytical Core
  14. Section 15: Overview of Signals — Typical Tabular Format
  15. Section 16: Signal and Risk Evaluation — Writing Guidance
  16. Crafting High-Quality Signal Narratives (Section 16)

  1. Sections 17–20: The Final Synthesis of Benefit and Risk
  2. Section 17: Benefit Evaluation
  3. Key Dimensions for the Benefit Narrative (Section 17)
  4. Section 18: Integrated Benefit-Risk Analysis — The Critical Section
  5. Integrated Benefit-Risk Assessment Framework
  6. Writing the Integrated Benefit-Risk Narrative
  7. Section 19: Conclusions and Actions
  8. Section 20: Appendices to the PBRER
  9. IPD Sharing Statements: Growing Regulatory Expectation

  1. Quality Control (QC) in PBRER Preparation
  2. Audit Readiness Checklist for PBRER Submission
  3. Site-Level Implementation and SOPs

  1. Global Variations in PBRER Requirements
  2. EU-Specific Requirements: The EURD List
  3. Final Synthesis: The Art and Science of PBRER Medical Writing
  4. PBRER Writing: Professional Development Pathways

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.)


Our Certified Customers

novartis
NHS
takeda
roche
dhl

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