Product information and information to the public

Topic outline

• Select section General

  General

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  After completing this course, you will be able to:

  • Describe the components of product information and access to information they contain
  • Outline the legal mandate and review process of product information
  • Explain the difference between advertising and promotion of medicines to the general public and healthcare professionals with reference to the legal framework
  • Explain the relation between different levels of Codes of Conduct and their differentiation to Codes of Ethics
  • Relate the EFPIA Code of Practice to the underlying EU Directive 2001/83

   

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• Select section Lesson 1: Product Information Regulation

  Lesson 1: Product Information Regulation

  Learning outcomes of this lesson:

  	Describe the components of product information and access to information they contain Outline the legal mandate and review process of product information

  • Select activity 1. Introduction

    

    1. Introduction Page

    Completion

    Learners must

    

    View
  • Select activity 2. Summary of Product Characteristics (SmPC)

    

    2. Summary of Product Characteristics (SmPC) Book

    Completion

    Learners must

    

    View
  • Select activity 3. Package Leaflet (PL)

    

    3. Package Leaflet (PL) Book

    Completion

    Learners must

    

    View
  • Select activity 4. Package labelling

    

    4. Package labelling Book

    Completion

    Learners must

    

    View
  • Select activity 5. European Public Assessment Report (EPAR)

    

    5. European Public Assessment Report (EPAR) Book

    Completion

    Learners must

    

    View
  • Select activity 6. National registers of authorised medicines

    

    6. National registers of authorised medicines Page

    Completion

    Learners must

    

    View
  • Select activity 7. Patients’ involvement in product information

    

    7. Patients’ involvement in product information Page

    Completion

    Learners must

    

    View
  • Select activity 8. What EMA publishes and when

    

    8. What EMA publishes and when Page

    Completion

    Learners must

    

    View
• Select section Lesson 2: Advertising and promotion of medicines to the public and to healthcare professionals

  Lesson 2: Advertising and promotion of medicines to the public and to healthcare professionals

  Learning outcomes of this lesson:

  	Explain the difference between advertising and promotion of medicines to the general public and healthcare professionals with reference to the legal framework

  
  
  

  • Select activity 1. Introduction

    

    1. Introduction Page

    Completion

    Learners must

    

    View
  • Select activity 2. European Legislation – Directive 2001/83

    

    2. European Legislation – Directive 2001/83 Book

    Completion

    Learners must

    

    View
  • Select activity References

    

    References Page

    Completion

    Learners must

    

    View
  • Select activity 3. Appendix I

    

    3. Appendix I Book

    Completion

    Learners must

    

    View
• Select section Lesson 3: Codes of Conduct

  Lesson 3: Codes of Conduct

  Learning outcomes of this lesson:

  	Explain the relation between different levels of Codes of Conduct and their differentiation to Codes of Ethics Relate the EFPIA Code of Practice to the underlying EU Directive 2001/83

  • Select activity 1. Introduction

    

    1. Introduction Page

    Completion

    Learners must

    

    View
  • Select activity 1.1. Definition of code of conduct

    

    1.1. Definition of code of conduct Page

    Completion

    Learners must

    

    View
  • Select activity 2. Levels of codes of conduct

    

    2. Levels of codes of conduct Page

    Completion

    Learners must

    

    View
  • Select activity 3. Scope and topics of codes of conduct

    

    3. Scope and topics of codes of conduct Book

    Completion

    Learners must

    

    View
  • Select activity 4. Digital communication channels

    

    4. Digital communication channels Page

    Completion

    Learners must

    

    View
  • Select activity 5. Revision and limits

    

    5. Revision and limits Page

    Completion

    Learners must

    

    View
  • Select activity References

    

    References Page

    Completion

    Learners must

    

    View
• Select section Assessment

  Assessment

  • Select activity Assessment

    

    Assessment Quiz

    Completion

    Learners must

    

    Receive a grade

    

    Receive a passing grade