Section: Lesson 1: Legal framework and main regulatory procedures for marketing authorisation | Regulatory procedures- Marketing-Authorisations and their lifecycle management | EUPATI Open Classroom

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Section outline

Learning outcomes of this lesson:
	Understand the basics of regulatory affairs functions in pharmaceutical companies Understand and explain the principal EU regulatory legal framework and procedures for authorising a medicine

Select activity 1. Introduction: Regulatory affairs in the medicines development process

1. Introduction: Regulatory affairs in the medicines development process Page

Learners must

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Select activity 2. Legal framework – EU legislation - EudraLex

2. Legal framework – EU legislation - EudraLex Book

Learners must

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Select activity 3. Legal bodies responsible for regulatory procedures

3. Legal bodies responsible for regulatory procedures Book

Learners must

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Select activity 4. Marketing authorisation

4. Marketing authorisation Page

Learners must

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Select activity 5. EU Regulatory procedures for a marketing authorisation (MA)

5. EU Regulatory procedures for a marketing authorisation (MA) Book

Learners must

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Select activity 6. Refusal of a Marketing Authorisation

6. Refusal of a Marketing Authorisation Page

Learners must

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