Adjusting the route to the market is vital to support innovation and timely approvals for products that could cover unmet or high medical needs. However, what remains unclear is how to shape regulatory strategy to overcome the barriers and whether the evidence gathered for authorisation marries up with the health technology assessment (HTA) strategy. Also the bottlenecks in bringing products onto the market and legislative frameworks at national level are of particular interest. The workshop aims to look into both the regulatory hurdles as well as discuss improvements in market access based on evidence from recent years and the situation in European countries. Insights from experts from both regulatory as well as market access side are brought to the table, connecting all stakeholders.
Registrations will be done through TOPRA website. More information and a detailed agenda will be available soon.
The workshop aims to discuss following key topics:
Current regulatory framework for adaptive pathways and its evolvement
How to use adaptive pathways for new products – experiences from professionals
EMA adaptive licencing pilot project
HTA approval for conditionally approved products in European countries – status quo
Additional evidence generation – how to tackle the challenges?
Political and public perception of limited evidence on safety and/or efficacy
US and EU frameworks – completely incompatible?