SafetyGlossary Term
ICH E2E
The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
Pharmacovigilance encompasses the comprehensive system of activities designed to monitor the safety of medicinal products throughout their entire lifecycle, from early clinical development through post-marketing surveillance. This discipline integrates scientific methodology, regulatory compliance, and public health protection to ensure that the benefits of therapeutic interventions continue to outweigh their risks across diverse patient populations and clinical settings. The ultimate goal of pharmacovigilance is to promote safe, effective use of medicines while minimizing preventable harm.
During clinical development, pharmacovigilance activities focus on identifying and characterizing the safety profile of investigational products through systematic collection, processing, and analysis of adverse event data. This includes establishing processes for adverse event reporting by investigators, coding and entering safety data into databases, detecting potential safety signals, conducting causality assessments, and preparing regulatory safety reports. The sponsor must maintain a pharmacovigilance system capable of fulfilling these obligations across all trials of the investigational product simultaneously.
Post-marketing pharmacovigilance continues the safety monitoring that began during clinical trials but extends to the much larger and more diverse population exposed to marketed products. Activities include operating adverse event reporting systems for healthcare professionals and consumers, conducting post-authorization safety studies, analyzing real-world data from electronic health records and claims databases, and implementing risk minimization measures when necessary. Regulatory requirements mandate that marketing authorization holders maintain pharmacovigilance systems, designate qualified persons responsible for pharmacovigilance, and submit periodic safety update reports summarizing the benefit-risk balance of their products.
System maintenance
"The sponsor's pharmacovigilance department maintained a global safety database that captured all adverse events from clinical trials and post-marketing sources, enabling integrated safety analysis across the product's development program."
Qualified Person designation
"In accordance with European regulations, the company designated a Qualified Person for Pharmacovigilance who was responsible for establishing and maintaining the pharmacovigilance system and ensuring compliance with all safety reporting obligations."
A response to a medicinal product that is noxious and unintended, where a causal relationship between the product and the adverse event is at least a reasonable possibility.
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product.
The strictest warning required by the FDA to appear on prescription drug labeling, alerting prescribers and patients to serious risks that may lead to death or severe injury.
The systematic evaluation of the likelihood that an adverse event was caused by the investigational product or another factor, using established criteria to determine the relationship between exposure and outcome.
A standardized one-page format developed by the Council for International Organizations of Medical Sciences for reporting suspected adverse drug reactions from clinical trials to regulatory authorities.
ICH E2E
The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
Pharmacovigilance encompasses the comprehensive system of activities designed to monitor the safety of medicinal products throughout their entire lifecycle, from early clinical development through post-marketing surveillance. This discipline integrates scientific methodology, regulatory compliance, and public health protection to ensure that the benefits of therapeutic interventions continue to outweigh their risks across diverse patient populations and clinical settings. The ultimate goal of pharmacovigilance is to promote safe, effective use of medicines while minimizing preventable harm.
During clinical development, pharmacovigilance activities focus on identifying and characterizing the safety profile of investigational products through systematic collection, processing, and analysis of adverse event data. This includes establishing processes for adverse event reporting by investigators, coding and entering safety data into databases, detecting potential safety signals, conducting causality assessments, and preparing regulatory safety reports. The sponsor must maintain a pharmacovigilance system capable of fulfilling these obligations across all trials of the investigational product simultaneously.
Post-marketing pharmacovigilance continues the safety monitoring that began during clinical trials but extends to the much larger and more diverse population exposed to marketed products. Activities include operating adverse event reporting systems for healthcare professionals and consumers, conducting post-authorization safety studies, analyzing real-world data from electronic health records and claims databases, and implementing risk minimization measures when necessary. Regulatory requirements mandate that marketing authorization holders maintain pharmacovigilance systems, designate qualified persons responsible for pharmacovigilance, and submit periodic safety update reports summarizing the benefit-risk balance of their products.
System maintenance
"The sponsor's pharmacovigilance department maintained a global safety database that captured all adverse events from clinical trials and post-marketing sources, enabling integrated safety analysis across the product's development program."
Qualified Person designation
"In accordance with European regulations, the company designated a Qualified Person for Pharmacovigilance who was responsible for establishing and maintaining the pharmacovigilance system and ensuring compliance with all safety reporting obligations."
A response to a medicinal product that is noxious and unintended, where a causal relationship between the product and the adverse event is at least a reasonable possibility.
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product.
The strictest warning required by the FDA to appear on prescription drug labeling, alerting prescribers and patients to serious risks that may lead to death or severe injury.
The systematic evaluation of the likelihood that an adverse event was caused by the investigational product or another factor, using established criteria to determine the relationship between exposure and outcome.
A standardized one-page format developed by the Council for International Organizations of Medical Sciences for reporting suspected adverse drug reactions from clinical trials to regulatory authorities.