International Society of Pharmacovigilance Special Interest Group

Bayer co-founded an International Society of Pharmacovigilance Special Interest Group to develop and share innovative risk minimisation methods and tools.

Summary  

  • What: In 2015, Bayer co-founded a Special Interest Group on Risk Minimisation Methods in Asia within the International Society of Pharmacovigilance.
  • Objective: The group brings together Asian regulatory authorities and international experts, aiming to develop and share innovative risk minimisation methods and tools.
  • Scope: The group includes representatives from Cambodia, Indonesia, Thailand and Vietnam.
  • Details: One of the group’s outputs is an open-source tool to facilitate the development of risk management guidelines.

Looking closer

In early 2015, Bayer co-founded a Special Interest Group on Risk Minimisation Methods in Asia within the International Society of Pharmacovigilance. The group brings together regulatory authorities from Southeast Asia and international experts to develop and share innovative risk minimisation methods and tools. It is chaired by a member of the Pharmacovigilance Risk Assessment Committee at the European Medicines Agency and operationally led by Bayer’s Head of Pharmacovigilance for China and Asia-Pacific. Within the geographic scope of the Access to Medicine Index 2016, the group include representatives from Cambodia, Indonesia, Thailand and Vietnam.

Given local capacity gaps in implementing the principles of proactive pharmacovigilance and risk minimisation, the group developed an innovative open-source tool to facilitate the development of risk management guidelines. The tool, launched in 2015, comprises a customisable template intended for health authorities in Asian countries to use to develop locally-appropriate guidelines, including the roles, responsibilities and obligations of different stakeholders (e.g., health authorities, health care providers, and the manufacturer or distributor holding a product’s license).

The group is now working to provide a number of related deliverables (e.g., methodological details for structured collection of safety information) to further support locally-appropriate pharmacovigilance capacity building. It plans to publish these in 2016-17, to make them available to a range of countries worldwide (not only in Asia).

Many companies measured by the Index work with individual regulatory bodies to build local pharmacovigilance capacity. Bayer’s participation in a broader partnership and its contribution to a versatile and customisable tool helps to build capacity more comprehensively and sustainably, at an institutional level.

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