The Convergence of HTA and Regulation: A New HTA Reality and Collaboration with Regulatory Agencies

Speaker(s)

Guardian M1, Santos Ivo R2, Cooke E3, Martin C4, Lipska I5
1EUnetHTA, Diemen, Netherlands, 2INFARMED, Lisbon, Portugal, 3EMA, Amsterdam, Netherlands, 4Ministry of Health, Madrid, Spain, 5Medical University of Gdańsk, Clinical Trials Center, Warsaw, Poland

With the implementation of the new HTA regulation it is expected to have a more systematic and synergic collaboration with regulatory agencies, namely the European Medicines Agency and EU Member States Agencies, taking into consideration the outcomes of the regulatory evaluation of new medicines and new indications. The interaction will be a reality in developing the HTA assessment, but the collaboration can be present in different phases of the life cycle, including horizon scanning, scientific advice, and generation of real-world evidence. This session will discuss how the different activities and remits of both regulatory and HTA assessment can be optimized if we are aiming at more convergence (regulatory & HTA) or the differences in the remits will prevail.

As speakers are confirmed, they will be added to the session description.

Code

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