Regulators in PREFER

To ensure the regulatory perspective is present throughout the project, we have created a regulatory stakeholder advisory group.

The project will include interviews and focus groups with European and US regulators. Information from these interviews and focus groups will be used when choosing methods to be tested in case studies.

REGULATORY ADVISORY GROUP

PREFER has formalised a structure for regulatory input to to the project with a stakeholder advisory group, where input is coordinated by the European Medicines Agency (EMA). This regulatory advisory group will not be responsible for the recommendations at the end of the project.This group includes:

• European Medicines Agency (EMA):
  • Committee for Medicinal Products for Human Use (CHMP)
  • Scientific Advice Working Party (SAWP)
  • Committee for Orphan Medicinal Products (COMP)
• FDA Center for Biologics Evaluation and Research (CBER)