• Manoj Swaminathan

Have you heard about WHOPVToolKit?

Many times, we come across Pharma companies that want to set up a Pharmacovigilance system but are clueless about how they should start. A similar situation may even be faced by some countries, which are not yet a part of the WHO Programme for International Drug Monitoring. The WHO PV Toolkit is a collection of resources and information needed for the practice of Pharmacovigilance. WHO has developed an interactive website and the same can be accessed from www.whopvtoolkit.org The primary objective for developing this ToolKit is to ensure that Pharmacovigilance practitioners in low- and middle-income countries get access to information on the processes and activities involved in Pharmacovigilance, and that too from a trusted source.



Ref: www.whopvtoolkit.org What are the Sections?

  1. Introduction - This section includes Pharmacovigilance basics and guidance regarding various Pharmacovigilance methods

  2. Pharmacovigilance Systems - This section provides guidance on setting up a functional national Pharmacovigilance Centre.

  3. Setting up a Pharmacovigilance Centre - As the name explains, this section guides steps, logistics as well as potential issues.

  4. WHO PIDM - This section provides guidance on the WHO Programme for International Drug Monitoring (PIDM) and how to join the same.

  5. Pharmacovigilance Data - This section provides information on how the collected data can be used or utilized.

  6. Signal Detection - This section provides information on identification methods and data mining.

  7. Benefit-Risk Assessment - This section provides information on the various benefit-risk assessment models and methods.

  8. Communication in Pharmacovigilance - This section provides guidance on the importance of communication in Pharmacovigilance, the methods to be used, and how to communicate during a crisis.

  9. Crisis Management - This section provides guidance on what is a crisis and how this can be managed.


There is also an exciting Quiz for those who know how to set up a Pharmacovigilance Centre. Further icing on the cake; there are lots of free and useful downloads too. There is also a video on benefit-risk assessment. The PV Toolkit is a fantastic initiative from WHO, which can benefit even the Pharma companies that want to set up a Pharmacovigilance System or redefine their existing systems. ed for the practice of Pharmacovigilance

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