top of page
About us
Meet the Experts
Leadership
Sustainability
Our News
HALOPV
Releases
Support and FAQs
Guides and Training
Pricing and license
Modules overview
- Products module
- Entities module
- Clinical Studies module
- ICSRs module
- Complaints module
- Literature module
- Device Incidents module
- Signals module
- Risks module
- Aggregate reporting module
- Labelling module
- PSMF module
- Requirements Intelligence module
- Data collection programs module
- Quality module
- Agreements module
- Submissions module
- Medical information and comm. module
Consulting
Hosting Services
Regulatory Intelligence
Events
Careers
More...
Use tab to navigate through the menu items.
CONTACT INSIFE
Pharmacovigilance Glossary
Adverse Drug Reaction (ADR)
Learn more
Adverse Event of Special Interest (AESI)
Learn more
Aggregate reports
Learn more
Association
Learn more
Benefit
Learn more
Benefit-risk assessments
Learn more
Benefit-risk balance (or effectiveness/risk)
Learn more
CIOMS- Council for International Organizations of Medical Sciences
Learn more
Case reports/ Individual Case Safety/Study Report (ICSR)
Learn more
Causal relationship
Learn more
Causality assessment
Learn more
Clinical development program
Learn more
Clinical trial, clinical study
Learn more
Company Core Data Sheet (CCDS)
Learn more
Company Core Safety Information (CCSI)
Learn more
Critical terms
Learn more
DME (Designated Medical Event)
Learn more
Data Monitoring Committee
Learn more
Dechallenge
Learn more
Development core safety information (DCSI)
Learn more
Development pharmacovigilance and risk management plan
Learn more
Disproportionality analysis
Learn more
Drug Abuse
Learn more
EUDRAGENE
Learn more
Efficacy
Learn more
EudraVigilance
Learn more
EudraVigilance Medicinal Product Dictionary (EVMPD)
Learn more
European Medicines Agency (EMA)
Learn more
Expected adverse drug reaction
Learn more
Expedited Reporting
Learn more
Frequency of ADRs
Learn more
Good pharmacovigilance practice (GDP)
Learn more
Harm
Learn more
Hazard
Learn more
ICH
Learn more
Important medical event (IME)
Learn more
Incidence
Learn more
Insife
Learn more
International Serious Adverse Events Consortium (iSAEC)
Learn more
Marketing Authorization Holder (MAH)
Learn more
Medical Dictionary for Regulatory Activities (MedDRA)
Learn more
Medication error
Learn more
Minimum criteria for reporting
Learn more
Missing information
Learn more
National pharmacovigilance centers or National Competent Authority (NCA)
Learn more
Near-misses
Learn more
Number needed to harm (NNH)
Learn more
Odds and Odds Ratio
Learn more
Off-label use or Misuse
Learn more
Overdose
Learn more
Pharmacoepidemiology
Learn more
Pharmacology
Learn more
Pharmacovigilance
Learn more
Pharmacovigilance System Master File (PSMF)
Learn more
Pharmacovigilance system
Learn more
Post-authorization safety study (PASS)
Learn more
Postmarketing surveillance
Learn more
Predisposing factors
Learn more
Prescription event monitoring (PEM)
Learn more
Prevalence
Learn more
QPPV
Learn more
Rational drug use (RDU)
Learn more
Rechallenge
Learn more
Reference risk (or baseline risk)
Learn more
Risk
Learn more
Risk Management Plan (RMP)
Learn more
Risk management
Learn more
Risk minimization activity
Learn more
Safety
Learn more
Safety concern
Learn more
Safety specification
Learn more
Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR)
Learn more
Signal
Learn more
Signal management process
Learn more
Signal validation
Learn more
Solicited reports
Learn more
Spontaneous reporting
Learn more
Summary of product characteristics (SmPC)
Learn more
Suspected unexpected serious adverse reaction (SUSAR)
Learn more
Temporal relationship
Learn more
Type (A to F) of adverse drug reaction
Learn more
Unexpected adverse drug reaction
Learn more
United States Prescribing Information (USPI)
Learn more
Unlabelled (or labelled)
Learn more
Vigibase
Learn more
WHO
Learn more
WHO DD (WHO Drug Dictionary)
Learn more
WHOART (WHO Adverse Reactions Terminology)
Learn more
bottom of page