Introduction to Regulatory Affairs

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• Select section General

  General

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  After completing this course, you will be able to:

  • Outline the principles of medicines regulation
  • Describe the legislative framework for medicines regulation
  • Describe the purpose and function of the International Council of Harmonisation and outcomes of its work
  • Explain the reasoning behind the implementation of the Common Technical Document
  • Understand the current EU regulatory requirements (pre and post-authorisation) for a medicinal product
  • Explain the concept of benefit and cost-effectiveness
  • Describe the various roles patients can play in approval and benefit-risk evaluation pre- and post-approval of medicines
  • Explain the role of modern pharmacopoeias
  • Describe the roles of the European Directorate for the Quality of Medicines (EDQM)
  • Understand and describe the key principles of GoodxPractice
  • Describe the key elements of GxPs most relevant in pharmaceutical medicine
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• Select section Lesson 1: Background and general principles of medicines regulation and its legislative framework

  Lesson 1: Background and general principles of medicines regulation and its legislative framework

  Learning outcomes of this lesson:

  	Outline the principles of medicines regulation   Describe the legislative framework for medicines regulation

  • Select activity 1. Medicines regulation - ensuring effective medicines with acceptable risk

    

    1. Medicines regulation - ensuring effective medicines with acceptable risk Book

    Completion

    Learners must

    

    View
  • Select activity 2. Legislative documents governing medicines regulation

    

    2. Legislative documents governing medicines regulation Book

    Completion

    Learners must

    

    View
  • Select activity 3. Stakeholders in the development of medicines legislation in the EU

    

    3. Stakeholders in the development of medicines legislation in the EU Page

    Completion

    Learners must

    

    View
  • Select activity 3.1 The European network in medicines regulation – National Competent Authorities (NCAs)

    

    3.1 The European network in medicines regulation – National Competent Authorities (NCAs) Page

    Completion

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  • Select activity 4. Guideline development in the EU

    

    4. Guideline development in the EU Page

    Completion

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  • Select activity 4.1 Implementation and status of CHMP guidelines

    

    4.1 Implementation and status of CHMP guidelines Page

    Completion

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    View
• Select section Lesson 2: Principles of medicines regulation at the global level

  Lesson 2: Principles of medicines regulation at the global level

  Learning outcomes of this lesson:

  	Describe the purpose and function of the International Council of Harmonisation and outcomes of its work Explain the reasoning behind the implementation of the Common Technical Document

  
  
  

  • Select activity The global perspectives in medicines development

    

    The global perspectives in medicines development Page

    Completion

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  • Select activity 2. Medicines regulation and collaboration at the global level

    

    2. Medicines regulation and collaboration at the global level Page

    Completion

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    View
  • Select activity World Health Organisation (WHO)

    

    World Health Organisation (WHO) Page

    Completion

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  • Select activity 4. International Council on Harmonisation (ICH)

    

    4. International Council on Harmonisation (ICH) Book

    Completion

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  • Select activity Additional resources

    

    Additional resources Page

    Completion

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    View
• Select section Lesson 3: Background and general principles of the regulatory approval of medicines

  Lesson 3: Background and general principles of the regulatory approval of medicines

  Learning outcomes of this lesson:

  	Understand the current EU regulatory requirements (pre and post-authorisation) for a medicinal product. Explain the concept of benefit-risk and cost-effectiveness Describe the various roles patients can play in approval and benefit-risk evaluation pre- and post-approval of medicines

  • Select activity 1. Background and general principles of the regulatory approval of medicines

    

    1. Background and general principles of the regulatory approval of medicines Page

    Completion

    Learners must

    

    View
  • Select activity 2. Benefit-risk assessment

    

    2. Benefit-risk assessment Page

    Completion

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    View
  • Select activity 3. Fulfilling medicines regulation during approval process in the EU

    

    3. Fulfilling medicines regulation during approval process in the EU Page

    Completion

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  • Select activity 4. Patients’ involvement in medicines regulation at the EMA

    

    4. Patients’ involvement in medicines regulation at the EMA Page

    Completion

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    View
  • Select activity 5. Benefit-risk evaluation at the time of approval

    

    5. Benefit-risk evaluation at the time of approval Page

    Completion

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  • Select activity 6. Cost-effectiveness evaluation post approval

    

    6. Cost-effectiveness evaluation post approval Page

    Completion

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  • Select activity 7. Benefit-risk of medicines post approval

    

    7. Benefit-risk of medicines post approval Page

    Completion

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  • Select activity 8. Tools in benefit-risk evaluation of medicines

    

    8. Tools in benefit-risk evaluation of medicines Page

    Completion

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  • Select activity 9. Patients’ views and involvement in benefit-risk evaluation

    

    9. Patients’ views and involvement in benefit-risk evaluation Page

    Completion

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    View
• Select section Lesson 4: Concept of pharmacopoeias

  Lesson 4: Concept of pharmacopoeias

  Learning outcomes of this lesson:

  	Explain the role of modern pharmacopoeias Describe the roles of the European Directorate for the Quality of Medicines (EDQM)

  • Select activity 1. History of pharmacopoeias

    

    1. History of pharmacopoeias Page

    Completion

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  • Select activity 2. Role of modern pharmacopoeias

    

    2. Role of modern pharmacopoeias Page

    Completion

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  • Select activity 2.1. Impurities controlled by EP monographs

    

    2.1. Impurities controlled by EP monographs Page

    Completion

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    View
  • Select activity 3. Roles of the European Directorate for the Quality of Medicines (EDQM) and the European Pharmacopoeia (EP) Commission in the medicines regulations system

    

    3. Roles of the European Directorate for the Quality of Medicines (EDQM) and the European Pharmacopoeia (EP) Commission in the medicines regulations system Page

    Completion

    Learners must

    

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• Select section Lesson 5: GoodxPractice (GxP)

  Lesson 5: GoodxPractice (GxP)

  Learning outcomes of this lesson:

  	Understand and describe the key principles of GoodxPractice Describe the key elements of GxPs most relevant in pharmaceutical medicine

  • Select activity 1. Introduction

    

    1. Introduction Page

    Completion

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  • Select activity 2. About Good 'x' Practice (GxP)

    

    2. About Good 'x' Practice (GxP) Book

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  • Select activity 3. Key GxPs in Medicine

    

    3. Key GxPs in Medicine Book

    Completion

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  • Select activity 4. Pharmaceutical Quality System (PQS)

    

    4. Pharmaceutical Quality System (PQS) Page

    Completion

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  • Select activity 5. Examples of GxPs (non-comprehensive list)

    

    5. Examples of GxPs (non-comprehensive list) Page

    Completion

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    View
• Select section Assessment

  Assessment

  • Select activity Assessment

    

    Assessment Quiz

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    Receive a grade

    

    Receive a passing grade