HAROM India
Resources

Pharmacovigilance glossary.

The key drug-safety terms explained in plain English — from ICSR and E2B(R3) to PSUR, GVP, MedDRA and QPPV.

Talk to a PV ExpertExplore the platform
A
Adverse Event (AE)
An unwanted or harmful reaction experienced with a medicine.
Aggregate report
A periodic summary safety report — such as a PSUR, PBRER or DSUR.
C
Causality
An assessment of how likely it is that a medicine caused an adverse event.
CDSCO
The Central Drugs Standard Control Organisation — India's drug regulator.
CIOMS I
A standard one-page form used to report an individual adverse event case.
D
DSUR
Development Safety Update Report — a periodic safety report for products in clinical development.
E
E2B(R3)
The international ICH electronic format (XML) for exchanging individual case safety reports.
EMA
The European Medicines Agency — the EU's medicines regulator.
EudraVigilance
The EMA's system for reporting and managing suspected adverse reactions.
Expectedness
Whether an adverse event is already a known, listed side effect of a medicine.
F
FAERS
The FDA Adverse Event Reporting System — the US database of adverse event reports.
FDA
The US Food and Drug Administration — the US medicines and food regulator.
G
GAMP 5
A best-practice framework for validating computerised systems used in regulated work.
GVP
Good Pharmacovigilance Practices — the EU rulebook for drug safety, organised into numbered Modules.
GxP
An umbrella term for 'good practice' quality standards in regulated industries.
I
ICH
The International Council for Harmonisation — the body that defines standards such as E2B(R3).
ICSR
Individual Case Safety Report — a single report that a patient had an adverse event with a medicine.
L
Literature monitoring
Regularly scanning scientific journals for new adverse-event cases or safety signals.
M
MAH
Marketing Authorisation Holder — the company that legally owns a medicine's licence.
MedDRA
The standard medical dictionary used to code adverse events and medical terms.
MedWatch 3500A
The standard US form for reporting an individual adverse event case.
MHRA
The UK's Medicines and Healthcare products Regulatory Agency.
N
Narrative
The written account that tells the story of an individual adverse event case.
P
PBRER
Periodic Benefit-Risk Evaluation Report — a periodic safety report for marketed products.
Pharmacovigilance (PV)
The science and practice of monitoring medicines for safety and reporting adverse effects.
PSMF
Pharmacovigilance System Master File — the document describing a company's PV system.
PSUR
Periodic Safety Update Report — a periodic safety report for marketed products.
Q
QMS
Quality Management System — the SOPs, controlled documents, CAPAs and training records that govern quality.
QPPV
Qualified Person for Pharmacovigilance — the EU-required person responsible for a company's PV system.
R
RMP
Risk Management Plan — a document describing how a medicine's risks are managed and minimised.
S
Seriousness
An assessment of how severe an adverse event is (e.g. life-threatening, hospitalisation).
Signal
A new or changing safety pattern that may indicate a risk and warrants evaluation.
SUSAR
Suspected Unexpected Serious Adverse Reaction — a serious, unexpected reaction in a clinical trial.
W
WHO
The World Health Organization, which coordinates international drug-safety monitoring.
WHODrug
The standard dictionary used to code medicines and substances.
#
21 CFR Part 11
The US FDA rule for trustworthy electronic records and electronic signatures.
Let's talk pharmacovigilance

Put these into practice with HAROM

From ICSR processing to E2B(R3) submissions, HAROM's platform and services turn these concepts into compliant, everyday operations.

Request a DemoContact Our Experts
Inspection
Ready
GovernanceControlled SystemsInspection-ReadyTrained Teams