“What new research can enable a joint approach by regulatory and HTA agencies to manage uncertainties for products using early access pathways?”
A collaborative Forum presented by CIRS and the Utrecht University WHO Collaborating Centre for Pharmaceutical Policy and Regulation
29th November 2018
This one-day Forum at the Sheraton Amsterdam Airport Hotel brought together regulatory, HTA, industry and academic perspectives. It aimed to identify novel areas of research that will improve how the uncertainties around the safety, efficacy (effectiveness) and value of therapies that use early access development programmes can be mitigated. Types of new research should be identified that can provide quantitative and qualitative actionable information to help inform efficient processes that can ensure medicines for high priority health care needs can benefit from aligned regulatory and HTA interactions and evidence generation to address stakeholder expectations.