Open only to full-conference registrants with a badge. Collect your ticket at the Solutions Circle check-in desk at least 15 min before session start. First-come, first-served seating; standby tickets issued when full. Seats held for 3 minutes after start time.
Description: Regulatory professionals will deepen their understanding of emerging Early Access pathways in the United Kingdom and gain practical strategies for accelerating the pathway from development to patient benefit. Attendees will have the opportunity to discuss and dissect what a process for conditional market access could look like and explore how these mechanisms can be leveraged to overcome common hurdles in bringing innovative diagnostics to market.
Through interactive dialogue, participants will be able to share real-world challenges and solutions to shape what works best in an early access pathway, from setting clear regulatory milestones, and planning evidence generation supported by real-world data. This session is especially valuable for those supporting early-stage and SME innovation, as it offers an opportunity to understand the development of risk-proportionate, streamlined routes to market, making them stronger advocates and strategic partners for their organisations.
This collaborative forum will help regulatory professionals to play a leading role in shaping and implementing best practices, ensuring that timely access to innovative diagnostics translates into tangible improvements for patient outcomes within the dynamic MedTech sector.
Learning Objectives:
Upon completion, participants will be able to describe the common challenges faced in early-stage and SME innovation, whilst advocating effectively for their organisations within the MedTech sector.
Upon completion, participants will be able to identify the Early Access pathway available for innovative diagnostics in the United Kingdom and understand the key regulatory milestones.
Upon completion, participants will be able to list ways to support a sustainable early access route to the United Kingdom market for innovative diagnostics.