Safety Terms (16)

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

The strongest warning that FDA requires in prescription drug labeling, highlighting serious or life-threatening risks.

An annual comprehensive safety report submitted by sponsors of investigational drugs to regulatory authorities summarizing the safety profile during the reporting period.

A standardized medical terminology used internationally by regulatory authorities and the pharmaceutical industry for coding adverse events and medical history.

FDA's program for reporting serious adverse events, product quality problems, and therapeutic inequivalence for human medical products.

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.

The document describing the pharmacovigilance system operated by a Marketing Authorization Holder for EU-approved medicinal products.

The designated EU-based individual responsible for the establishment and maintenance of a Marketing Authorization Holder's pharmacovigilance system.

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

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

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.

The set of activities performed to detect, validate, confirm, analyze, prioritize, assess, and manage safety signals for a medicinal product.

A serious adverse event suspected to be related to the investigational product that is not expected based on the current Investigator's Brochure.