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

EUPATI Open Classroom

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Sectieoverzicht

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

Selecteer activiteit 1. Introduction: Regulatory affairs in the medicines development process

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

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Selecteer activiteit 2. Legal framework – EU legislation - EudraLex

2. Legal framework – EU legislation - EudraLex Boek

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Selecteer activiteit 3. Legal bodies responsible for regulatory procedures

3. Legal bodies responsible for regulatory procedures Boek

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Selecteer activiteit 4. Marketing authorisation

4. Marketing authorisation Pagina

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

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

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Selecteer activiteit 6. Refusal of a Marketing Authorisation

6. Refusal of a Marketing Authorisation Pagina

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