Introduction to Regulatory Affairs
Topic outline
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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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Learning outcomes of this lesson:
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Outline the principles of medicines regulation
-
Describe the legislative framework for medicines regulation
-
-
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
-
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
-
Learning outcomes of this lesson: - Explain the role of modern pharmacopoeias
- Describe the roles of the European Directorate for the Quality of Medicines (EDQM)
-
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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Introduction to Regulatory Affairs
-
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