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.
