After completing the course, you will be able to:
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Outline the principles of medicines regulation
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Describe the legislative framework for medicines regulation
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Describe the purpose and function of the International Council of Harmonisation and outcomes of its work
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Explain the reasoning behind the implementation of the Common Technical Document
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Understand the current EU regulatory requirements (pre and post-authorisation) for a medicinal product
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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
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Explain the role of modern pharmacopoeias
- Describe the roles of the European Directorate for the Quality of Medicines (EDQM)
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Understand and describe the key principles of GoodxPractice
- Describe the key elements of GxPs most relevant in pharmaceutical medicine
Duration: 10 hours
