empirica Communication and Technology Research based in Bonn, Germany, is a private research and consultancy specialised in innovation processes and the management of large-scale European projects for both private and public clients. empirica has established itself as a leading European and global institute with a broad understanding of the political, strategic, clinical, business and socio-economic questions raised by health system change and eHealth tools. It has provided services to the European Parliament, European Commission, WHO, OECD, European Space Agency, national and regional governments, healthcare providers, and global eHealth industrial players.
Main tasks in the projectempirica is leading WP9 on dissemination, impact, sustainability and exploitation including tasks on regulatory strategy and HTA issues as follows:
- EMP will design and execute the dissemination and communication plan
- EMP is responsible for carrying out a socio-economic and healthcare system impact assessment, taking into account impact on digital health policy
- EMP will set up a Regulatory Sub-Committee (RSC) with members of WP2, WP3, WP6, WP8, EFPIA partners, external HTA experts (AQuAS), and other organisations with experience, such as C-Path. The RSC will seek consultation with the EMA Innovation Taskforce (ITF) on FS data and the CVS protocol. This feedback will be incorporated in the finalised CVS protocol. Advice will also be obtained on how to gain EMA qualification advice.
- EMP will develop a sustainability strategy, business plan, and exploitation plan.