Analysis and development

ATMP Denmark conducts analyses and pilot projects to create a stronger knowledge base and develop solutions that can support the program’s strategic ambition. The work should help identify recommendations for a future ATMP Denmark as a single coordinated point of entry for knowledge and guidance on ATMP.

The analyses and pilot projects are to be carried out within three areas:

• Regulatory frameworks
  Map challenges and barriers on the path from research to launch and clinical implementation of ATMP – and develop and test concrete solutions in the work with regulatory support.
  

• Follow-up with real world data
  Develop strategies for how best to monitor the development and implementation of ATMP in practice.
  

• International inspiration
  Gather and analyze experiences from other countries.

From analysis to concrete solutions
The analyses must be translated into solutions that can support ATMP Denmark in becoming a coordinated point of entry.

The analyses in the regulatory track are prepared in collaboration with Sarah Wadmann, senior researcher at VIVE, and Jakob Wested, associate professor at the Faculty of Law, University of Copenhagen. Sarah Wadmann researches the implementation of new health technology, including prioritization dilemmas and organizational issues associated with the clinical implementation of ATMP. Jakob Wested’s research focuses on medicinal product regulation, including legal issues concerning ATMP.

Knowledge is collected, among other things, through workshops with our stakeholders, as well as in meetings with the working groups established to contribute to the ATMP program’s work.

The consultancy firm, NHTA, translates the results into concrete digital solutions for ATMP Denmark – including for the knowledge bank.