Topic outline
General
Lesson 1: Legal framework and main regulatory procedures for marketing authorisation
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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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Book
Lesson 4: Use of medicines outside of or without a marketing authorisation
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Assessment
Quiz