In this workshop, CIRS brought together senior representatives from regulatory agencies, pharmaceutical companies and academia from 18 countries across the Americas, Africa, Asia and Europe, to examine risk-based approaches in more detail. The aim was to identify what is needed for risk-based approaches to work effectively and efficiently, incorporating lessons learned from the various models being implemented around the world.

This multi-stakeholder workshop consisted of a series of presentation sessions, panels and three parallel breakout discussions. Presentations explored the current global landscape of risk-based models, learnings from unilateral reliance models, implementing good reliance practices, leveraging information from reference agencies, facing internal barriers to reliance and learnings from regional and trans-regional risk-based models.

The breakout groups were asked to discuss and develop recommendations on three topics:

  • Regional collaboration – What are the key considerations or frameworks that enable the construction and delivery of an efficient and effective regional/trans-regional model?
  • Changing mindsets – How can this best be achieved within companies and agencies to enable reliance and collaborative models?
  • Good collaborative practices – What needs to be in place in companies and agencies to move from principle to implementation?

This workshop synopsis summarises key messages and recommendations from the presentations and breakout discussions.

CIRS February 2024 Workshop synopsis front cover