Data & Quality
Pharmacovigilance
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems, across both clinical trial and post-marketing settings.
In clinical development, pharmacovigilance encompasses safety database management, signal detection, periodic aggregate reporting (DSURs during trials, PSURs/PBRERs post-approval), and risk management plans (RMPs/REMS).
Modern pharmacovigilance is governed by ICH E2A; E2F, EMA's GVP modules, and FDA's 21 CFR 312.32 for IND safety reporting.
Related terms
Adverse Event (AE)
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant administered a pharmaceutical product, regardless of whether it is considered related to the product.
Serious Adverse Event (SAE)
A Serious Adverse Event (SAE) is any adverse event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, is a congenital anomaly, or is an important medical event per investigator judgment.
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is the international ethical and scientific quality standard, codified in ICH E6, for designing, conducting, recording, and reporting clinical trials that involve human participants.
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