Topic outline

General

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

100% Complete
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

Page
1. Introduction: Regulatory affairs in the medicines development process Page
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2. Legal framework – EU legislation - EudraLex Book
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3. Legal bodies responsible for regulatory procedures Book
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4. Marketing authorisation Page
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5. EU Regulatory procedures for a marketing authorisation (MA) Book
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6. Refusal of a Marketing Authorisation Page

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

100% Complete
Learning outcomes of this lesson:
Lesson 2
  • Understand and describe the main special cases in marketing authorisations and their particular conditions
  • Explain the non-standard procedures for marketing authorisations and their differences
  • Describe the main variation types of a marketing authorisation



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1. Non-standard marketing authorisations Book
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2. Accelerated assessment Page
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3. Special cases in marketing authorisations: Orphan Medicines Book
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4. Special cases in marketing authorisations: Advanced therapy medicines (ATMPs) Book
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5. Special cases in marketing authorisations: Paediatric medicines Book
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6. Special cases in marketing authorisations:Homeopathic medicines Book
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7. Special cases in marketing authorisations: Herbal medicines Book
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8. Post-Approval Book
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Additional resources Page

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

100% Complete
Learning outcomes of this lesson:
Lesson 3

Page
1. Introduction and recap Page
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2. Pre-submission Book
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3. Format of the Submission – the Common Technical Document (CTD) Book
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4. Submission Book
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5. Assessment, opinion and EC decision Page
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6. Tabular recap of the procedural steps of a MAA Page
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7. Types of Marketing Authorisation Applications Book
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References legal basis Page

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

100% Complete
Learning outcomes of this lesson:
Lesson 4



Page
1. Introduction Page
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2. Early access Book
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3. Off-label use Book

Assessment

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Quiz
Assessment Quiz