Topic outline

General

Lesson 1: Legal framework and main regulatory procedures for marketing authorisation

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Learning outcomes of this lesson:
Lesson 1
  • 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

Lesson 2: Non-standard and special cases of marketing authorisations and post-approval regulatory management of marketing authorisations

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Lesson 3: Principles and submission of Marketing Authorisation Applications (MAAs) and their types, including the Common Technical Document (CTD)

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Lesson 4: Use of medicines outside of or without a marketing authorisation

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Learning outcomes of this lesson:
Lesson 4



Assessment

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