Risk Minimisation – design, implementation & evaluation

PrimeVigilance’s experts have been developing and implementing additional risk minimisation measures (aRMMs) for products from various disease areas according to the requirements of the EU PV legislation, as part of REMSs, and for global risk minimisation approaches.

PrimeVigilance has successfully developed and implemented electronic risk minimisation tools, such as educational websites or Smartphone Apps, including the adaptation to the specific requirements of different EU and non-EU countries. We see the possibilities offered by new two-way communication channels about risks as a major transformative factor for pharmacovigilance in the near future.

Furthermore, PrimeVigilance has helped companies in the development and implementation of processes for the systematic planning and execution of aRMMs globally. PrimeVigilance has also designed and implemented measures and studies for the evaluation of risk minimisation tool effectiveness.