Opções de inscrição

Introduction to Regulatory Affairs
 
After completing the 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
  • Duration: 10 hours
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Esta disciplina exige uma taxa de inscrição.

Custo: EUR 10,00

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