Ethics in Regulatory Affairs of Pharmaceutical Products - Dilemmas in Decision-makings – University of Copenhagen

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Ethics in Regulatory Affairs of Pharmaceutical Products: Dilemmas in Decision-makings

Ethical dilemmas are embedded in the lifecycle of all medicinal products and are becoming a growing factor in the approval process for pharmaceutical products. Pharmaceutical companies and regulatory authorities need to be able to grasp this challenge imposed by ethical dilemmas in order to ensure a transparent and effective approval of the drug candidate.

Combining knowledge from regulatory science at the University of Copenhagen with know-how from leading experts from industry, medicines agencies and patient organisations, this groundbreaking course will provide the course participant with a comprehensive overview of the ethnical challenges present in the different stages of the lifecycle of medicinal products.

Learn to navigate the ethical responsibilities of a regulatory professional

The course gives you competencies and tools to manage your role as a regulatory professional within the pharmaceutical industry in regard to ethics and dilemmas in decision-making. Focus will be on your role throughout the process of development, approval and the life cycle of a pharmaceutical product.  

After completion of the course you will be able to

  • identify and analyse ethical dilemmas within the pharmaceutical regulatory field and thereby improving the ability to propose innovative solutions targeted at protecting health volunteers and patients from avoidable harm
  • better understand the role of assessing benefit-risk as a part of lifecycle of medicines enabling you to ensure that all relevant information is available for assessment
  • strategically work with ethical, societal and HTA aspects of regulation of medicines
  • independently take responsibility to further develop professionally as a regulatory professional within the pharmaceutical field, e.g. in balancing professional ethics, risk/benefit and other assessments, as well as requirements and interests of stakeholders.

You will obtain knowledge about 

  • Requirements to obtain marketing authorisations in EU and USA, with a focus on benefit-risk assessment of drugs and patients aspects
  • Regulatory compliance as important aspects of roles and responsibilities of regulatory professionals
  • The patient perspective and involvement in medicines development and regulatory assessment.
  • Ethical challenges for decision-making:
    • Phase 1 to 4 seen from various stakeholders perspectives
    • Why, when and how to involve patients
    • Why, when and how to involve HTA bodies

Course dates:

  • 3-6 October 2017 The course is postponed til 2018. Dates to be announced.

Course fee:

  • DKK 15,000 for EU/EEA citizens (12,800 for students enrolled in the Master's programme)
  • DKK 17,068 for non-EU/EEA citizens (14,868 for students enrolled in the Master's programme)

Application deadline: