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About

This course provides an introduction to global pharmacovigilance principles, focusing on ICH guidelines such as E2C(R2) for PBRER and E2F for DSUR. It covers the transition from safety-only reporting to integrated benefit-risk evaluation across major markets including the FDA and EMA. Students will learn the structured preparation of aggregate reports and the importance of literature screening in regulatory compliance.

The course delivers a comprehensive look at the lifecycle of safety reporting, from Individual Case Safety Reports (ICSRs) to periodic aggregate reports like the PBRER. Key topics include signal management, causality assessment using WHO-UMC and Naranjo scales, and the evaluation of Risk Management Plans (RMPs). It emphasizes practical literature monitoring strategies, the use of GxP-qualified platforms, and the assessment of risk minimization effectiveness. Professionals will gain a strong foundation in managing global pharmacovigilance obligations and literature-based surveillance.

Course Syllabus

  1. The Role of Scientific and Medical Literature in Pharmacovigilance
  2. What Literature Screening Captures That Spontaneous Reporting Misses
  3. Safety Signals: Definition and Management Process
  4. Passive Surveillance: How Spontaneous Reporting Works
  5. Individual Case Safety Reports (ICSRs): Criteria and Process
  6. Case Series Reports: Signal Generation in Literature
  7. Causality Assessment: Determining Drug Responsibility
  8. WHO-UMC Causality Assessment Scale
  9. The Naranjo Algorithm: Quantitative Causality Assessment
  10. WHO-UMC vs. Naranjo: Choosing the Right Tool

  1. Overview: The Suite of Pharmacovigilance Summary Reports
  2. Periodic Safety Update Report (PSUR): The Historical Standard
  3. The Evolution: From PSUR to PBRER
  4. The Periodic Benefit-Risk Evaluation Report (PBRER): Value and Utility
  5. The Risk Management Plan (RMP): Proactive Safety Management
  6. Risk Management Plan: Three Core Parts
  7. Risk Minimization Measures: Routine vs. Additional
  8. Usefulness of the Risk Management Plan
  9. Development Safety Update Report (DSUR): Annual Reporting in Development
  10. PSUR / PBRER / DSUR: Comparison at a Glance

  1. Active Surveillance: Beyond Spontaneous Reporting
  2. WHO Typology: Three Types of Active Surveillance
  3. Patient Registries: Design and Role in Active Surveillance
  4. PRAC Impact Strategy: Measuring What Pharmacovigilance Achieves
  5. PRAC Impact Strategy: Four Key Activity Areas
  6. PRAC Impact Research: The Reality of Risk Minimization Effectiveness

  1. Risk Minimization Activities: Definition and Scope
  2. Enablers of Effective Risk Minimization
  3. Analytical Methods for Measuring Risk Minimization Impact
  4. Why Screen Medical Literature to Identify Adverse Drug Reactions?
  5. Literature as an Early Warning System: The Thalidomide Story
  6. The Thalidomide Tragedy: A Timeline
  7. Challenges with Screening Scientific and Medical Literature

  1. The Global Regulatory Landscape for Pharmacovigilance
  2. FDA vs. EMA: Key Differences in Pharmacovigilance Requirements
  3. Building a Validated Literature Search Strategy
  4. Building the Search String: Essential Components
  5. Recall vs. Precision: The Core Search Performance Metrics
  6. The Large and Growing Volume of Scientific Literature
  7. EMA Medical Literature Monitoring (MLM) Service
  8. Implementing EMA MLM Results: What MAHs Must Do
  9. Monitoring Local Language Journals: A Regulatory Expectation
  10. Pharmacovigilance Inspections and Audits
  11. In-House vs. Outsourcing Literature Monitoring
  12. Outsourcing Is Not Without Its Risks

  1. Why Software? The Compelling Case for Literature Management Automation
  2. Core Features of Literature Management Solutions
  3. QUOSA PV: Overview of the Platform
  4. What Does QUOSA Do? Key Functional Capabilities
  5. Who Is QUOSA For? Users and Use Cases
  6. Why Choose QUOSA? Key Value Propositions
  7. How Does QUOSA Work? The Workflow Process
  8. ReadCube and AI-Powered Literature Surveillance

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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