The document discusses various basic terminologies used in pharmacovigilance including: 1. Adverse events, adverse drug reactions, and their definitions. 2. Other terms like causality assessment, benefit risk analysis, biological products, and their brief descriptions. 3. Software and databases used for pharmacovigilance like VigiBase, Vigiflow, Vigimine, and VigiSearch.

1. NAME :- Mayur Dipak Mohite
Class :- Final Year
Roll no :- 27
Topic Name:- Basic Terminologies Used In
Pharmacovigilance.

2. Adverse Event (AE): It can also be called as adverse experience . Any
Unintended, untoward or unexpected, medical incidence or clinical
Investigation undergoing in a patient administered with the medical drug,
Which might or might not necessarily have any causal relationship with the
Drug.
Adverse Drug Reaction (ADR): As per WHO, adverse drug reaction can be
defined as “any response to a drug which is noxious and unintended, and which
occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of
disease, or for the modification of physiological function.
Association : Events associated in time but not necessarily linked as cause and
effect.
Benefit risk analysis: It refers to examination of the favourable (beneficial) and
unfavourable results undertaking a specific course of action.
Biological product : Medical products prepared from biological material of
human, animal or microbiologic origin (such as blood products, vaccines,
insulin).

3. Causality assessment : The evaluation of the likelihood that a medicine was the
causative agent of an observed adverse reaction. Causality assessment is usually
made according established algorithms.
Causal relationship : It means a relationship between one phenomenon or event (A
and another (B) in which precedes and causes B. In pharmacovigilance -a medicine
causing an adverse reaction.
CemFlow : Software developed by UMC for collection and analysis of data in Cohort
Event Monitoring.
VigiBase: The name of the WHO Global CSR Database is called Vigi Base.
Vigimed: Share point based conferencing facility, exclusive to member countries of
the WHO Programme for International drug Monitoring for fast communication of
topical pharmacovigilance issues.

4. Vigiflow: VigiFlow is a complete ICSR management system created and
maintained by the UMC .It is web-based and built to adhere to the ICH E28
standard. It can be used as the national database for counties in the WHO
Programme as it incorporates tools for report analysis. and facilitates sending
reports to VigiBase.
Vigimine: A statistical tool within VigiSearch with vast statistical material
calculated for all drug AOR pairs (combinations) available in VigiBase. The 1nain
features include the disproportionality measure (IC value) stratified in different
ways and useful filter capabilities.
VigiSearch: A search service for accessing ICSRs stored in the VigiBase database
offered by the UMC to national pharmacovigilance centres and other third-party
inquirers.
WHO-ART: This is the terminology for coding clinical information in relation to
drug therapy. WHO ART is maintained by UMC.
Pani-Fiow: Software developed by UMC for collection and analysis of data in
relations of vaccination in the pandemic situation.

5. Rechallenge: It is a point at which the recipient administers repeats a medicine
once the previous dose is extracted out.
Dechallenge: It indicates the withdrawal of a drug from a patient. It is that
condition at which the adverse effects might disappear, get reduced, or the
continuity might get broken down.
Individual Case Safety Report (ICSR): It is a document containing complete
information associated to an individual case. This is provided by a primary source to
describe alleged adverse reactions related to the administration of one or more
medicinal products to a particular patient at a certain point of time.
Prescription Only Medicine (POM): The therapeutic drug or medicinal product
becomes available to the public only on showing prescription.
Serious Adverse Event or Reaction: It can be defined as any unintended , or
untoward medical intervention at any dose resulting in significant disability or life
threatening death.