Principal Regulatory Consultant Parexel International
In the wake of the pandemic and Brexit, the European landscape of expedited designations and pathways, and pilot programs has been altered as European regulators changed the framework of pathways to better suit the needs of novel and innovative products in development.
The concept of an accelerated pathway often generates interest, but applicants can struggle with the respective eligibility criteria and generating the right data at the right time. Furthermore, the increased range of choice can make deciding which pathway to use a challenge.
This session will map out expedited pathways in Europe and provide recommendations on how best to utilize them. Three years on from Brexit, the session will also cover how the UK’s expedited options fit in with the EU’s and how they can be best used. Finally, it will highlight the Simultaneous national scientific advice (SNSA) pilot launched by the EU Innovation Network in November 2022.
Learning Objectives:
List and describe the various expedited pathways in Europe
Detail the opportunities and identify the obstacles associated with each program
Decide which EU/UK expedited pathway would be suitable for their product