Executive Director's Office

Executive Director's Office

Rúna Hvannberg Hauksdóttir

Executive Director's office consists of in total seven functions and divisions  (Executive Director, Quality Management, Legal Affairs, Human Resource Management, Change Management, Clinical Division and Information Division)

 

Quality Management

Bjarni Þórisson

  • Management and operation of the Icelandic Medicines Agency's IT quality management system.
  • Establishing, implementing and maintaining a document controlled and effective quality management system.
  • Management and implementation of the Icelandic Medicines Agency's quality policy.
  • Quality management advice and support within the Icelandic Medicines Agency.
  • Participation in the international Working Group of Quality Managers (WGQM) and the Benchmarking of European Medicines Agencies.
  • Implementing and maintaining an effective internal audit system, including Pharmacovigilance audits.
  • Implementation of an overall system for complaints handling.
  • Cross-functional quality management projects, including the implementation of ISO 9001 and ÍST 85.

 

Human Resource Management

Sigurlaug K. Jóhannsdóttir

  • HR process development and implementation of best practices
  • Human Resource management and oversight including
    • Recruitment, reception of new employees and retirement 
    • Support and HR consultation for employees and management
    • Employee conversations and performance evaluation (oversight)
    • Time recording, salaries and organizational contracts.
  • Development and implementation of the human resource strategy
  • Development of re-education policy, implementation and follow up

 

Legal Affairs

Fjóla Pétursdóttir

  • Resolution of legal issues
  • Legal counselling
  • Review of complaints
  • Review of proposed legislation Bills and regulations
  • Supervision of court cases
  • Review of legal contracts
  • Legal assessments
  • Committee participation
  • International cooperation

 

Change Management

Inga Rósa Guðmundsdóttir

  • Strategy management:
    • IMA strategy implementation and maintenance
    • Strategy process performance management
  • Process development and implementation of IMA strategy maintenance
  • Apply a structured methodology and lead change and process management activities
  • Support to management and employees

 

 Clinical Division

Kolbeinn Guðmundsson

  • Scientific Advice (member of the Scientific Advice Working Party)
  • Committee for Medicinal Product for Human Use Participation (CHMP)/ member and clinical assessments as rapp and co rapp for generic and originator medicines
    • Assessment and advice regarding:
    • Named-patient basis use applications
    • Clinical trials in Iceland
    • Periodic Safety Update Report (PSUR)
    • Adverse events reporting
  • Cross agency advice/consultancy 

 

Information Division

Jana R. Reynisdóttir

  • Communicating information
  • Education
  • Publication
  • Statistics
  • Public relations
  • Events