Topic outline
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Learning outcomes of this lesson:
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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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Learning outcomes of this lesson:
- 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
- Describe the purpose and function of the International Council of Harmonisation and outcomes of its work
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Learning outcomes of this lesson: - Understand the current EU regulatory requirements (pre and post-authorisation) for a medicinal product.
- Explain the concept of benefit-risk 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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Learning outcomes of this lesson: - Explain the role of modern pharmacopoeias
- Describe the roles of the European Directorate for the Quality of Medicines (EDQM)
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Learning outcomes of this lesson: - Understand and describe the key principles of GoodxPractice
- Describe the key elements of GxPs most relevant in pharmaceutical medicine
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View
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Receive a grade Receive a passing grade
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