Safety Terms (16)
16 terms that appear in safety planning, review, and readiness workflows.
Medical Dictionary for Regulatory Activities(MedDRA)
A standardized medical terminology used internationally by regulatory authorities and the pharmaceutical industry for coding adverse events and medical history.
MedWatch(MedWatch)
FDA's program for reporting serious adverse events, product quality problems, and therapeutic inequivalence for human medical products.
Periodic Benefit-Risk Evaluation Report(PBRER)
A periodic safety report format harmonized by ICH for presenting comprehensive benefit-risk analysis of medicinal products.
Periodic Safety Update Report(PSUR)
A periodic report summarizing the global safety profile of a marketed medicinal product.
Pharmacovigilance(PV)
The science and activities relating to the detection, assessment, understanding, and prevention of adverse drug reactions.
Pharmacovigilance System Master File(PSMF)
The document describing the pharmacovigilance system operated by a Marketing Authorization Holder for EU-approved medicinal products.
Risk Evaluation and Mitigation Strategy(REMS)
A drug safety program required by FDA for certain medications with serious safety concerns to ensure benefits outweigh risks.
Risk Management Plan(RMP)
A document describing safety activities to identify, characterize, prevent, and minimize risks relating to medicinal products.
Serious Adverse Event(SAE)
An adverse event that results in death, is life-threatening, requires hospitalization, causes disability, or is a congenital anomaly.
Signal Detection
The process of identifying new or changing safety information from pharmacovigilance data that may require further investigation.
Signal Management(Signal Management)
The set of activities performed to detect, validate, confirm, analyze, prioritize, assess, and manage safety signals for a medicinal product.
Suspected Unexpected Serious Adverse Reaction(SUSAR)
A serious adverse event suspected to be related to the investigational product that is not expected based on the current Investigator's Brochure.
