Safety Terms (25)

Any untoward medical occurrence in a patient or clinical trial subject administered a pharmaceutical product.

CIOMS guides risk surveillance, reporting discipline, and benefit-risk decision updates.

CPV guides risk surveillance, reporting discipline, and benefit-risk decision updates.

Development SAFETY UPDATE REPORT guides risk surveillance, reporting discipline, and benefit-risk decision updates.

Individual CASE SAFETY REPORT supports pharmacovigilance operations that protect patients and satisfy authority expectations.

Medwatch is a safety governance concept used to detect, evaluate, and mitigate post-market risks.

Nitrosamine RISK Assessment is a safety governance concept used to detect, evaluate, and mitigate post-market risks.

A periodic safety report format harmonized by ICH for presenting comprehensive benefit-risk analysis of medicinal products.

A periodic report summarizing the global safety profile of a marketed medicinal product.

The science and activities relating to the detection, assessment, understanding, and prevention of adverse drug reactions.

QPPV guides risk surveillance, reporting discipline, and benefit-risk decision updates.

Quality RISK Management is a safety governance concept used to detect, evaluate, and mitigate post-market risks.

RISK BASED Monitoring guides risk surveillance, reporting discipline, and benefit-risk decision updates.

A drug safety program required by FDA for certain medications with serious safety concerns to ensure benefits outweigh risks.

A Risk Evaluation and Mitigation Strategy (REMS) is an FDA-required safety program used when routine labeling alone is insufficient to manage serious risks.

RISK Management guides risk surveillance, reporting discipline, and benefit-risk decision updates.

A document describing safety activities to identify, characterize, prevent, and minimize risks relating to medicinal products.

RISK Management PLAN UPDATE guides risk surveillance, reporting discipline, and benefit-risk decision updates.

RISK Minimization guides risk surveillance, reporting discipline, and benefit-risk decision updates.

SAFETY SIGNAL is a safety governance concept used to detect, evaluate, and mitigate post-market risks.

SAFETY Specification guides risk surveillance, reporting discipline, and benefit-risk decision updates.

An adverse event that results in death, is life-threatening, requires hospitalization, causes disability, or is a congenital anomaly.

The process of identifying new or changing safety information from pharmacovigilance data that may require further investigation.

SIGNAL Management guides risk surveillance, reporting discipline, and benefit-risk decision updates.

SUSAR is a safety governance concept used to detect, evaluate, and mitigate post-market risks.