Topic outline

General

Lesson 2: Principles of medicines regulation at the global level

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Learning outcomes of this lesson:
Lesson 2
  • 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



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1. The global perspectives in medicines development Page
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2. Medicines regulation and collaboration at the global level Page
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3. World Health Organisation (WHO) Page
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4. International Council on Harmonisation (ICH) Book
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Additional resources Page

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

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Learning outcomes of this lesson:
Lesson 3
  • 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

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1. Background and general principles of the regulatory approval of medicines Page
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2. Benefit-risk assessment Page
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3. Fulfilling medicines regulation during approval process in the EU Page
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4. Patients’ involvement in medicines regulation at the EMA Page
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5. Benefit-risk evaluation at the time of approval Page
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6. Cost-effectiveness evaluation post approval Page
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7. Benefit-risk of medicines post approval Page
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8. Tools in benefit-risk evaluation of medicines Page
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9. Patients’ views and involvement in benefit-risk evaluation Page

Lesson 4: Concept of pharmacopoeias

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Learning outcomes of this lesson:
Lesson 4
  • Explain the role of modern pharmacopoeias
  • Describe the roles of the European Directorate for the Quality of Medicines (EDQM)

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1. History of pharmacopoeias Page
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2. Role of modern pharmacopoeias Page
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2.1. Impurities controlled by EP monographs Page
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3. Roles of the European Directorate for the Quality of Medicines (EDQM) and the European Pharmacopoeia (EP) Commission in the medicines regulations system Page

Lesson 5: GoodxPractice (GxP)

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Learning outcomes of this lesson:
Lesson 5
  • Understand and describe the key principles of GoodxPractice
  • Describe the key elements of GxPs most relevant in pharmaceutical medicine

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1. Introduction Page
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2. About Good 'x' Practice (GxP) Book
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3. Key GxPs in Medicine Book
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4. Pharmaceutical Quality System (PQS) Page
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5. Examples of GxPs (non-comprehensive list) Page

Assessment

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Quiz
Assessment Quiz