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Pharma Glossary

The definitive, structured ontology of pharmaceutical, biotechnology, and medical device acronyms, regulations, and terminology.

All Terms Biotechnology Clinical Trials Manufacturing Pharmacovigilance Quality Assurance Regulatory Affairs
A B C D E I L M P Q R S
A
ADR Pharmacovigilance
Adverse Drug Reaction.
Local Context (Ireland/EU): A response to a medicinal product which is noxious and unintended, where a causal relationship between product and event is suspected.
AE Pharmacovigilance
Adverse Event.
Local Context (Ireland/EU): Any untoward medical occurrence in a patient or subject administered a drug. Reports are managed in the EU via EudraVigilance.
PGO Reference: http://purl.obolibrary.org/obo/PGO_0000042
B
Benefit-Risk Balance Pharmacovigilance
The relationship between the positive therapeutic effects of a product compared to its risks (safety issues).
Local Context (Ireland/EU): Regulators continuous evaluate this balance; a negative shift can lead to drug suspension or withdrawal.
C
CIOMS Pharmacovigilance
Council for International Organizations of Medical Sciences.
Local Context (Ireland/EU): An international body that publishes consensus guidelines for drug safety reporting formats (e.g., CIOMS I forms).
D
DSUR Pharmacovigilance
Development Safety Update Report.
Local Context (Ireland/EU): The safety report submitted annually by sponsors during the clinical trial/development phase of an investigational drug.
E
EudraVigilance Pharmacovigilance
The central European database managed by the EMA to collect and monitor suspected adverse reactions to medicines.
Local Context (Ireland/EU): All marketing authorization holders in Ireland must integrate their safety databases with EudraVigilance.
I
ICSR Pharmacovigilance
Individual Case Safety Report.
Local Context (Ireland/EU): The standard electronic format used to report a single suspected adverse reaction case associated with a medicine.
L
LSO Pharmacovigilance
Local Safety Officer.
Local Context (Ireland/EU): The designated pharmacovigilance contact in a specific country, responsible for national reporting and communication with the local regulator (HPRA).
M
MedDRA Pharmacovigilance
Medical Dictionary for Regulatory Activities.
Local Context (Ireland/EU): The global standard medical terminology used to classify adverse event reports and medical diagnoses.
P
PAES Pharmacovigilance
Post-Authorisation Efficacy Study.
Local Context (Ireland/EU): A clinical trial required to address efficacy questions that could not be resolved before marketing authorization.
PASS Pharmacovigilance
Post-Authorisation Safety Study.
Local Context (Ireland/EU): A study carried out after a medicine is authorized to identify, characterize, or quantify a safety hazard or evaluate risk management effectiveness.
PSUR Pharmacovigilance
Periodic Safety Update Report.
Local Context (Ireland/EU): A pharmacovigilance document providing an evaluation of the risk-benefit balance of a medicine, submitted at defined time points post-approval.
Q
QPPV Pharmacovigilance
Qualified Person Responsible for Pharmacovigilance.
Local Context (Ireland/EU): An EU-mandated executive responsible for the establishment and maintenance of the safety database and system for a marketing authorization holder.
R
RMP Pharmacovigilance
Risk Management Plan.
Local Context (Ireland/EU): A detailed description of the risk management system required in the EU for identifying and minimizing the safety risks of a medicine.
S
SAE Pharmacovigilance
Serious Adverse Event.
Local Context (Ireland/EU): An event resulting in death, life-threatening situation, hospitalization, persistent disability, or congenital anomaly.
Signal Detection Pharmacovigilance
The systematic search for new risks or safety changes by looking at adverse event database trends.
Local Context (Ireland/EU): EMA mandates ongoing signal detection using global healthcare registry databases.