Policy, Regulatory and International Affairs

The Policy, Regulatory and International Affairs unit is involved in regulatory and governmental-legal matters, strategic development, international affairs, administration and decision-making processes of the Medicines Evaluation Board and Agency and represents the organisation at the (inter)national level.

The unit is responsible for the MEB-wide tasks in the field of:

  • European representation of the MEB in Europe in general committees, such as the CHMP, PRAC, CMD, PDCO, COMP and CAT and in general national forums, such as meetings of umbrella organisations, ministries, working parties;
  • Governmental-legal affairs: Procedures relating to the Freedom of Information Act (FOIA), objections and appeals, advice on national and European law, governance, integrity, transparency policy;
  • Governmental affairs, such as supporting the MEB (monitoring decision-making processes, coordination between Pharmacotherapeutic groups and the MEB), organisation of various consultation forums of the MEB such as the Authorisation Contact Committee (CCR), Practice Committee, Patient consultation, and supporting the chairmen, directors and management teams, Advisory Board;
  • Policy development, strategy determination and international affairs of the MEB, (inter)national and European support and processing of internal and external regulatory problems.

Head of unit

Mr. dr. D.S. (Diederick) Slijkerman