Topic outline

General

Lesson 2: Principles of medicines regulation at the global level

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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


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

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Lesson 4: Concept of pharmacopoeias

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Lesson 5: GoodxPractice (GxP)

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Learning outcomes of this lesson:

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

Assessment

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