This Workshop built on previous CIRS global development workshops as well the work being undertaken by various groups in the areas of good regulatory and review practices and focused specifically on the risk-based prioritisation of the review process for new medicines.

Workshop objectives

  • Identify the current risk-based prioritisation evaluation models of decision making being used for the review of medicines and what are believed to be the benefits and hurdles of utilising these in the review of new medicines
  • Discuss the frameworks and decision-making practices that need to be in place to enable effective and efficient prioritised risk-based decision making
  • Make recommendations on practical and acceptable review models to evolve and ensure success of risk-based evaluation approaches to decision making that allow agencies to focus on value-added activities and provide timely patient availability to good quality medicines that are safe and effective