SUMMARY

Ongoing Pharmacovigilance is a critical component of public health, ensuring the ongoing monitoring and assessment of drug safety to protect patients, and maintain the integrity of the healthcare system. Post-market surveillance for medicinal products is an integral part of Market Authorization in the EU, US, and other pharmaceutical markets.Data Collection and Reporting in pharmacovigilance involve spontaneous reporting, where healthcare professionals, patients, and consumers voluntarily report adverse drug reactions (ADRs) to regulatory authorities or pharmaceutical companies. Literature monitoring entails the regular review of scientific literature and medical publications to identify potential safety concerns. Signal detection utilizes statistical methods and data analysis to identify patterns or signals indicating potential safety issues, followed by signal validation to determine causal relationships. Data Management involves establishing centralized databases to collect and manage information on adverse events, along with standardizing coding systems for categorization. Risk Assessment includes determining the likelihood of a drug’s responsibility for reported adverse events and evaluating the overall benefits and risks through benefit-risk analysis. Regulatory Reporting includes mandatory reporting requirements for pharmaceutical companies to submit safety update reports and promptly report serious adverse events, ensuring compliance with regulations. Communication and Information Dissemination involves issuing alerts and warnings about safety concerns to healthcare professionals, patients, and the public, along with educational initiatives for safe medication use. Risk Management Strategies encompass implementing measures to minimize identified risks, such as changes in product labeling or additional warnings, and conducting post-marketing studies to further investigate safety concerns in real-world settings. Collaboration and Networking involve international collaboration with regulatory agencies and organizations to share information and coordinate global pharmacovigilance efforts, as well as building networks with healthcare professionals, academia, and industry stakeholders to enhance surveillance capabilities.