Work Packages

The aim of this project is to develop, implement and establish evidentiary standards and methods to address the data and evidentiary needs of regulatory authorities and HTA bodies towards a more efficient use of RWD for the development, registration and assessment of medicinal products in Europe.

The key aims of More-EUROPA are revealed in its work packages (WPs):

  • WP1: Development of novel analytical tools (evidentiary standards)
  • WP2: Establishing RWD accessibility and usefulness (case studies)
  • WP3: Identifying and screening suitable registry-based RWD (screening tool)
  • WP4: Ethical perspectives and patient empowerment for RWD use (ethical and patient perspective)
  • WP5: Dissemination: Guideline development, training and implementation (adoption and use)
  • WP6: Project Management, ensuring a smooth functioning and successful execution of the project.