Learning Outcome – University of Copenhagen

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Master of Medicines Regulatory Affairs > About the programme > Learning Outcome

Learning Outcome

Knowledge

A Master in Medicines Regulatory Affairs will be able to:

  • Explain, identify and discuss, based on the best international research, scientific problems that arise in the development of medicines.
  • Explain, identify and discuss key elements of global (e.g. EMA, FDA) regulatory legislation and regulatory procedures.
  • Explain and discuss, based on the best international research, key elements of medicines regulatory affairs aspects of quality development, non-clinical development, and clinical development.
  • Identify and discuss key elements included in a marketing authorization application (MAA).
  • Explain and discuss, based on the best international research, key elements in global regulatory affairs e.g. effectiveness, patient involvement, pharmacovigilance, health technology assessment and their implications for product development and evaluation.

Skills

A Master of Medicines Regulatory Affairs will be able to:

  • Apply, analyze and consider key scientific elements in regulatory legislation and regulation guidelines.
  • Evaluate the possibilities for obtaining a marketing authorization (MA) for a given medicinal product.
  • Apply, analyze and consider key elements in the interface between chemistry, manufacturing and control (CMC), pharmaceutical development, non-clinical as well as clinical data.
  • Evaluate the possibilities, benefits and consequences of seeking scientific advise with regulatory authorities.
  • Apply, analyze and perform ongoing benefit/risk assessment throughout the lifecycle of a medicinal product.
  • Critically examine and evaluate scientific data and conclusions intended for regulatory review.
  • Advise on, and formulate effective responses to complex practical regulatory issues.
  • Discuss ethical, societal and health economical aspects of patient involvement in medicines development.
  • Advise and train leaders and employees in regulatory aspects of medicines development, as well as communicate and discuss evidence-based knowledge within that area with researchers (specialists, and non-specialists) or lay-persons within or outside the employing organization.

Competences

A Master in Medicines Regulatory Affairs will be able to:

  • Initiate and facilitate interaction between applicants and regulatory authorities based on scientific questions.
  • Enable application of new methods, technologies and strategies to aid successful medicines development and regulatory review.
  • Advise on and identify solutions that enable improvement of the regulatory environment by implementing and upholding regulatory compliance and good regulatory practices.
  • Advise on and develop plans that facilitate a safe, innovative and effective approval of medicines.
  • Independently assess and organize their own learning process and assume responsibility for continuous professional development with a view to life-long learning.