Regulatory Science – Perspectives on Clinical Development – University of Copenhagen

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Master of Medicines Regulatory Affairs > Courses > Regulatory Science – P...

Better your ability to work strategically with the regulatory process

The course will present current perspectives on and innovations in drug regulation in clinical development with focus on four selected topics. It enables students to critically reflect and discuss guidelines, regulations and legislation within clinical development of medicine. Hereby giving the students tools to nuance their current knowledge on guidelines and regulations and work strategically with the regulatory processes.

The course focuses on 4 hot topics in the Regulatory Science of Clinical Development. The students will gain knowledge to impact discussions on strategic regulatory decisions on following topics:

  • Patient involvement in drug development
  • Benefit-risk assessment
  • Accelerated approval pathways
  • Impact of pharmacovigilance

 You can join the course independently or it can serve as an extension of the course Clinical Development – Efficacy of medicines.

The course is taught at the University of Copenhagen in collaboration with the Copenhagen Centre for Regulatory Science (CORS).

What will you gain?
After you have completed the course you will have gained knowledge that allows you to reflect and discuss critically on guidelines and regulations for clinical development of medicines.

  • You will be able to explain the perspectives of current regulatory frameworks in clinical drug development.
  • You will have gained knowledge about requirements and possible challenges for obtaining marketing authorization.
  • You will be able to evaluate and discuss research results within Regulatory Science.
  • You will be equipped to navigate in a continuously changing regulatory system
  • You will have gained knowledge that allows you to discuss the advantages of latest regulatory innovations in in clinical drug development.
  • You will be prepared to critically reflect on the appropriateness of different regulatory strategies.

Course dates:

  • 20 + 27 November 2017

Exam dates:

  • to be announed

Course fee:

  • DKK 7,500 for EU/EEA citizens
  • DKK 8,534 for non-EU/EEA citizens

Application deadline:

  • 25 September 2017