Vigiflow is a web-based system for managing individual case safety reports (ICSRs) related to adverse drug reactions and events. It allows for complete data entry on reported cases and integrated dictionaries to help with correct coding. Vigiflow provides easy connection between regional and national servers to share reported case data. While it offers free-text fields and constant data sharing, some disadvantages include potential server issues between countries and need for fast internet connections. Vigiflow has been used since 2001 and allows authorities and companies to manage safety report databases and conduct data analysis.

1. VIGIFLOW
Presented by :
Mr. Kajale Fulchand Vishwanath
M.Pharm first year 2ñd semester
Guided by:
Ms. Shagufta Farooqui
Assistant professor
Department of Pharmacology
Shri Sharda Bhavan Education Society’s
Nanded Pharmacy College Nanded
Presentation on

2. Content
• What is VigiFlow
• History
• Creating a new report
• General reporting
• Report information section
• Study information tab
• Advantages
• Disadvantages
• Reference
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3. What is VigiFlow ?
• VigiFlow is a web-based ICSR data management system
• It is complete easy management system of ICSR (individual
Case safety reporting ).
• Vigiflow can be used by any authority or company as a database
for report management and data analysis .
• Vigiflow is not primarily tool of UMC (Uppsala monitoring
center) but the data can be transferred to UMC.
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4. HISTORY:
• Vigiflow was initiated in the year 2001 when swiss medic
required a new pharmacovigilant body.
• Vigiflow was created with name ADR PLOT .
• It was supported with primary reporting facility 7 regional
centre in 4 languages.
• The first reporting was done in year 2003 at Ghana.
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5. CREATING A NEW REPORT:
• Once we load to new report option there are two sub option.
• Standard case:
In standard case, cases with ADR , ADE , side effect , drug
reaction or reaction due to possible drug administration etc.
• Parent child case :
A parent child case is filled when the child is suffering from an
ADE / ADR due to medication taken by parent.
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6. General reporting
• General reporting can be done by regional centre it consists
of various important section to be filled.
• Sender’s information
• In sender information various mandatory section like fillers
name, address, designation, date, time and location.
• Report information
• This contain details about event.
• Name/date of birth/age /age group, weight, gender
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7. • Current/ Past drug therapy
• This contain any drug treatment in the current or past time
section must be Filled with details like
• Drug name
• Indication
• Reaction observed
• Reaction observed
• Reaction list of code reaction causality assessment, onset of
reaction end time of reaction , duration of reaction outcome
of reaction details of any treatment given to counteract the
reaction drug dose.
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8. Drug consumed
• List of drug as treatment for the reaction, Drug name dose
• Assessment given
• Assessment can be either be physically or Therapeutically
• Overview of case
• This is a free text which includes case narrative, Sender’s
comments Sender’s diagnosis (MED DRA or ICD 10).
International Classification of Diseases –Medical Dictionary
for Regulatory Activities
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9. Image.no 1 Reporting of adverse drug reactions in VigiFlow
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10. Report information section
Spontaneous: For adverse events collected from the spontaneous
reporting system the report type
Spontaneous report applies
Study: For adverse event reports collected from studies Report
from study applies
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Image no 2 Report information section

11. Study Information Tab
Study type: select as applicable (e.g. Clinical trials)
Study name: enter as applicable according to study title (e.g. An
international randomized trial of additional treatments for COVID-
19 in hospitalized patients who are all receiving the local standard
of care)
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Image no 3 study information tab

12. Adverse reaction section
Reaction/event : Structure the Reaction/event using the appropriate
MedDRA term.
Use the +Sign to structure multiple reactions e.g. If Lack of
therapeutic efficacy
• Reaction/event as reported by initial reporter: enter the
Reaction/event as described by the initial reporter.
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Image no 4 Adverse reaction section

13. Suspected ingredient
• It is possible to indicate which component of the medicinal
product is the suspect of causing the events according to the
following list
• Active ingredient
• Preservative
• Antioxidant
• Stabilizer
• Colour
• Flavouring agent
• Solvent
• Constituent
• Excess percent
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Image no 5 suspected ingredients

14. • Advantages
• Free text providing complete data entry
• Easy and constant connection between regional and national
servers
• Integrated dictionaries which helps correct coding .
• Disadvantages
• Server of different country might have glitch in uploading.
• Need faster internet server.
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15. Conclusions
• VigiFlow is a web-based ICSR data management system that
is used reporting of adverse drug reactions.
• It is easy and constant connection between regional and
national servers.
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16. Reference
• https://who-umc.org/pv-products/vigiflow
• https://who-umc.org/media/165665/1-introduction-and-basic-
features-of-vigiflow.pdf
• https://www.mdpi.com/1660-4601/19/6/3264/htm
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