How to navigate the future parallel HTA and EMA processes in the EU

The first-ever Joint Clinical Assessment (JCA) submissions under the HTA Regulation are getting closer. Regulatory submissions through the centralized procedure after 12 January 2025 to the European Medicines Agency (EMA) will also trigger the JCA process. Both processes will run in parallel, and the new legislative framework for the exchange of information between regulators and HTA will take effect. The new process will require close collaboration between the regulatory and HTA/market access teams at the company level.

This in-person course will discuss regulatory preparedness for the JCA process, explain the interface between regulators and EU HTA Coordination Group and which information is shared by the two. The instructors have been very close to the HTA Regulation implementation activities in companies and with the policymakers.

Swiss Biotech Members receive a 10% discount on the standard registration fee. Please reach out to the Swiss Biotech Association Academy for more details: orbit@swissbiotech.org