Pharmacovigilance Course

Lesson 1 • Core Terminology and Definitions

Defines adverse event, adverse drug reaction, signal, and related terms. Precise vocabulary underpins accurate case reporting and regulatory communication.

Lesson 2 • Stakeholders in the PV Ecosystem

Maps roles of manufacturers, regulators, healthcare providers, and patients. Understanding stakeholder responsibilities clarifies accountability in safety reporting.

Lesson 3 • International PV Frameworks Overview

Surveys harmonized guidelines and regional regulatory expectations for drug safety. Provides the regulatory landscape students will navigate throughout the course.

Lesson 1 • Aggregate and Periodic Reporting

Introduces periodic safety update reports and development safety update reports. Aggregate reports synthesise cumulative safety data for regulatory benefit-risk review.

Lesson 2 • Spontaneous Reporting Fundamentals

Explains voluntary reporting by healthcare professionals and patients. Spontaneous reports form the backbone of post-market safety surveillance worldwide.

Lesson 3 • Digital Reporting Tools and Portals

Surveys electronic submission platforms and safety database interfaces. Proficiency with digital tools accelerates reporting accuracy and reduces submission errors.

Lesson 4 • Mandatory Expedited Reporting

Covers regulatory timelines and criteria for expedited safety reports. Timely submission of serious unexpected reactions is a core compliance obligation.

Lesson 1 • Key Causality Criteria in Practice

Applies temporal relationship, dechallenge, rechallenge, and alternative explanations. Practical application of criteria ensures consistent and defensible causality conclusions.

Lesson 2 • Standardised Assessment Algorithms

Compares WHO-UMC, Naranjo, and other validated causality scales. Students select the appropriate tool based on data availability and reporting context.

Lesson 3 • Principles of Causality Assessment

Defines causality in pharmacoepidemiology and its regulatory significance. Establishes the conceptual basis for all structured assessment methods taught in this chapter.

Lesson 1 • Signal Validation and Triage

Applies clinical and statistical criteria to confirm or refute detected signals. Validation prevents unnecessary regulatory action on false-positive statistical findings.

Lesson 2 • Signal Management Documentation

Structures signal tracking logs, assessment reports, and governance records. Robust documentation satisfies regulatory inspection requirements and supports audit readiness.

Lesson 3 • Signal Detection Concepts

Defines a safety signal and explains its lifecycle from hypothesis to confirmed risk. Foundational understanding enables students to distinguish noise from actionable safety information.

Lesson 4 • Quantitative Signal Detection Methods

Covers disproportionality analysis including PRR, ROR, and EBGM statistics. Quantitative methods allow systematic screening of large spontaneous reporting databases.

Lesson 1 • Characterising Benefits of a Medicine

Identifies and quantifies clinical benefits from trial and real-world evidence. Accurate benefit characterisation is essential for balanced and credible benefit-risk conclusions.

Lesson 2 • Benefit-Risk Concepts and Frameworks

Introduces qualitative and quantitative benefit-risk frameworks used by regulators. Understanding framework options allows selection of the most appropriate approach for each product.

Lesson 3 • Integrating and Communicating Benefit-Risk

Synthesises benefit and risk data into a structured conclusion with uncertainty acknowledgment. Effective communication of benefit-risk supports regulatory decision-making and prescriber guidance.

Lesson 1 • Routine Risk Minimisation Measures

Covers labeling, package inserts, and prescribing information as primary risk tools. Routine measures form the first line of risk communication for all authorised medicines.

Lesson 2 • Effectiveness Evaluation of Risk Measures

Measures whether risk minimisation activities achieve their intended behavioural outcomes. Evaluation data inform plan updates and demonstrate regulatory compliance over time.

Lesson 3 • Additional Risk Minimisation Measures

Designs controlled distribution, educational programmes, and pregnancy prevention plans. Additional measures are applied when routine labeling is insufficient to manage serious risks.

Lesson 4 • Safety Specification Development

Identifies important identified, potential, and missing information risks. A thorough safety specification drives proportionate and targeted risk minimisation activities.

Lesson 1 • Post-Authorisation Safety Studies

Designs PASS protocols to address specific safety questions imposed by regulators. PASS studies fulfil regulatory commitments and generate evidence for benefit-risk updates.

Lesson 2 • Bias and Confounding in Safety Studies

Identifies selection bias, information bias, and confounding by indication. Recognising and controlling bias is essential for producing credible pharmacoepidemiological evidence.

Lesson 3 • Epidemiological Study Designs for Safety

Compares cohort, case-control, and cross-sectional designs for drug safety questions. Study design selection determines the strength of causal inference achievable from real-world data.

Lesson 4 • Real-World Data Sources

Surveys claims databases, electronic health records, and registries as PV data sources. Understanding data source characteristics is critical for valid study design and interpretation.

Lesson 1 • PV System Requirements and Documentation

Defines the components of a compliant PV system including the master file. A well-documented system demonstrates regulatory compliance and supports inspection readiness.

Lesson 2 • Corrective and Preventive Action Management

Designs CAPA plans to address audit findings and prevent recurrence. Effective CAPA management closes compliance gaps and demonstrates regulatory responsiveness.

Lesson 3 • Conducting Internal PV Audits

Applies audit methodology to assess PV process compliance against standards. Internal audits identify gaps before regulatory inspections and drive continuous improvement.

Lesson 4 • Regulatory Inspection Preparation

Prepares teams for announced and unannounced PV inspections by regulators. Proactive preparation reduces inspection findings and demonstrates organisational PV maturity.