Special Interest Groups - Risk Minimisation Methods for Asian countries

Setting up a SIG on Risk Minimization Methods in Asia

During the 14th Annual ISoP meeting in Tianjin in October 2014, the idea of taking the initiative to create this SIG was shared with ISoP Executive Committee members, who were encouraging the founders to proceed as appropriate. The mandates of the SIG will be:

  • Provide a forum to exchange experience on risk minimization methods, tools, and operational practices
  • Monitor the development of mobile device technologies applied to safety information enforcement and data collection, looking for affordable but effective and innovative risk minimisation solutions
  • Elaborate an array of solutions for risk-based risk minimisation which can be operated in diverse non-ICH countries i.e. addressing methods, tools as well as operational aspects
  • Elaborate training materials to promote the deployment of those solutions elaborated by the Group
  • Communicate on those solutions and advocate for their deployment in the different sub-regions of Asia and beyond

The SIG Risk Minimization Methods in Asia was officially announced at the Prague General Assembly, in October 2015, during the 15th ISoP Annual Meeting in Prague (Czech Republic).

The SIG RM Asia is pleased to share the poster which was presented at the Annual Meeting in Prague (Abstract P 046 – Drug Safety Abstracts book – Vol 38, No 10); click here

Next steps

Since Prague meeting, the SIG is moving ahead designing novel methods suitable for a large array of health care systems. Those methods will be customisable in order to make them applicable in a risk proportionate manner. The Post-Approval Vigilance Program (PAVP) concept, under preparation, is aimed to be applicable in any country including those having implemented a pharmacovigilance system only recently. It is also aimed to address the needs of countries facing a strong reluctance of health care professionals to report suspected adverse drug reactions. Other concepts will be worked out in subsequent steps. Our goal is to start communicating on those methods from May 2016 and to provide a consolidated picture at the 16th Annual ISoP Meeting in Agra.