Section outline

  • After completing this course, you will be able to:
    • Outline the principles of medicines regulation
    • Describe the legislative framework for medicines regulation
    • Describe the purpose and function of the International Council of Harmonisation and outcomes of its work
    • Explain the reasoning behind the implementation of the Common Technical Document
    • Understand the current EU regulatory requirements (pre and post-authorisation) for a medicinal product
    • Explain the concept of benefit and cost-effectiveness
    • Describe the various roles patients can play in approval and benefit-risk evaluation pre- and post-approval of medicines
    • Explain the role of modern pharmacopoeias
    • Describe the roles of the European Directorate for the Quality of Medicines (EDQM)
    • Understand and describe the key principles of GoodxPractice
    • Describe the key elements of GxPs most relevant in pharmaceutical medicine
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