Pharmaceutical Industry Pharmacovigilance & Drug Safety

Explore good pharmacovigilance practices (GVP) for medicines and how EMA and EU authorities monitor safety. Learn the 12 GVP principles, including quality management, master file, inspections, and risk management.

Learn how the pharmacovigilance quality management system ensures compliant policies, procedures, and systems for detecting, assessing, and reporting adverse effects, with strong leadership, document control, and ongoing improvements.

Explain the significance of pharmacovigilance quality management systems, highlighting trained personnel, documented procedures, and robust facilities, to ensure compliance, risk mitigation, and business continuity through audits, reviews, and performance indicators.

Learn how the pharmacovigilance system master file documents the holder’s structure, practices, and performance, and how pharmacovigilance inspections, including routine, for cause, pre-authorization, post-authorization, remote or surprise, assess compliance.

Explore good pharmacovigilance practices through audit and risk management systems, focusing on risk-based auditing and life-cycle risk management plans with safety specifications and post-authorisation safety studies.

Learn how adverse drug reactions are collected, verified, and submitted in pharmacovigilance, including the evaluation of ICSRs, reporting, sharing with regulators, and safeguarding patient data.

Understand periodic safety update reports (PSURs) as pharmacovigilance tools for post-authorization risk-benefit assessment, addressing new safety data, urgent information, and evolving risk management.

Explore post-authorisation safety study (pass) to detect safety risks and assess risk management, using interventional and non-interventional designs, including pharmacoepidemiology and observational methods.

Explore signal management and additional monitoring in pharmacovigilance, using case safety reports, active surveillance, and literature to reassess a drug's benefit-risk profile post-authorization.

Safety communication conveys mandatory product information and new safety data to patients and health care professionals, supporting timely, clear risk information and informed medication use.

Learn how risk minimization measures reduce adverse drug effects and maximize safe use across a product’s life cycle. Explore education programs, monitoring, and targeted patient selection to implement risk strategies.

Identify signals of adverse or beneficial drug reactions by evaluating data from nonclinical studies, clinical studies, spontaneous reporting, and active surveillance; then assess signal strength to guide actions.

Identify signals using four methods: clinical review of individual events, clinical review of collated events, record linkage, and automated signal detection, supported by IC values and PRR analyses.

Strengthen signals through validation by reviewing data, analyzing non-random patterns, and consulting panels, then gather pharmacovigilance data from Umc database, PubMed, and postmarketing surveillance to assess pharmacology plausibility and significance.

Explore pharmacovigilance indicators to measure structural, process, and outcome aspects of drug safety, using unbiased metrics and data from national and local sources to improve patient protection.

Explore how causality assessment in pharmacovigilance determines whether a drug caused an adverse drug reaction. Evaluate temporal relationships, biological plausibility, dechallenge and rechallenge, and the probability of a drug–event link.

Explore the WHO UMC causality assessment system for adverse drug events, detailing six categories—from certain to unclassifiable—and criteria that distinguish certain from probable.

Explore algorithmic causality assessment in pharmacovigilance, including the Naranjo adverse drug reaction probability scale and Bayesian methods combining prior probability, likelihood ratios, and posterior odds.

Explore active and passive pharmacovigilance surveillance, including spontaneous and stimulated reporting, cohort event monitoring, and cross-sectional, case-control, and cohort studies used for drug safety monitoring.

Explore how spontaneous reporting by health professionals detects adverse drug reactions and supports pharmacovigilance. Understand under-reporting, data limitations, and the role of icsrs and pharmacovigilance centers in identifying safety signals.

Learn WHO criteria for spontaneous reporting, including the required information in an Icpsr report, the role of pharmacovigilance centres, and the availability of multiple reporting methods.

Cohort event monitoring records all events after starting a monitored medication, not just adverse ones, and yields incident rates, safety signals, and comparative risk assessments.

Explore cohort event monitoring as an observational method to assess outcomes, the treated group, comorbidities, immortal time bias, and data collection for confounding control.

Compare cohort event monitoring and spontaneous reporting in pharmacovigilance, weighing data richness and early signals against data limitations, costs, and global familiarity.

Develop a consumer reporting system with forms, staff training, and consumer education to capture adverse drug reactions from the general public, OTC and herbal meds, store reports in a database.

Understand how an individual case safety report (Icsr) documents suspected adverse event details, capturing patient background, suspected medicines, risk factors, and reporter contact.

Identify patient, medication, and environmental risk factors through pharmacovigilance and pharmacoepidemiology, using post-marketing safety data, cohort monitoring, and statistical methods to assess drug risk.

Evaluate premarket benefit-risk by analyzing disease impact, target population, current treatments, and data on efficacy, safety, tolerability, and labeling, to forecast outcomes and guide approval decisions.

Explains postmarket benefit-risk assessment, detailing data sources, ongoing FDA evaluation, and the role of benefit risk planning to reduce uncertainty and guide regulatory decisions.