Regulatory procedures- Marketing-Authorisations and their lifecycle management

Topic outline

• General

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

  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

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    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

  Learning outcomes of this lesson:

  	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)

  Learning outcomes of this lesson:

  	Describe and discuss the regulatory steps in a marketing authorisation application (MAA) for a medicine, including the different types of MAAs and their legal basis

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    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

  Learning outcomes of this lesson:

  	Describe the EU provisions for early access and use of medicines outside of or without a marketing authorisation

  
  
  

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

• Assessment
  • Receive a grade Receive a passing grade

    Assessment Quiz