Section: Lesson 1: Background and general principles of medicines regulation and its legislative framework | Introduction to Regulatory Affairs | EUPATI Open Classroom

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Section outline

Learning outcomes of this lesson:

Outline the principles of medicines regulation

Describe the legislative framework for medicines regulation

Select activity 1. Medicines regulation - ensuring effective medicines with acceptable risk

1. Medicines regulation - ensuring effective medicines with acceptable risk Book

Learners must

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Select activity 2. Legislative documents governing medicines regulation

2. Legislative documents governing medicines regulation Book

Learners must

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Select activity 3. Stakeholders in the development of medicines legislation in the EU

3. Stakeholders in the development of medicines legislation in the EU Page

Learners must

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Select activity 3.1 The European network in medicines regulation – National Competent Authorities (NCAs)

3.1 The European network in medicines regulation – National Competent Authorities (NCAs) Page

Learners must

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Select activity 4. Guideline development in the EU

4. Guideline development in the EU Page

Learners must

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Select activity 4.1 Implementation and status of CHMP guidelines

4.1 Implementation and status of CHMP guidelines Page

Learners must

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