Drug Regulatory Science – University of Copenhagen

Master of Medicines Regulatory Affairs > Courses > Drug Regulatory Science

25 May 2018

Drug Regulatory Science

The course will enable the students to impact discussions on strategic regulatory decisions, and to critically reflect and discuss previously obtained knowledge about guidelines and regulations for clinical development of medicine. 

Regulatory science research will set the foundations for class discussion centred around research methodology and methods, identification of data sources, and interpretation of research results.

The course will centre around 3-4 regulatory science research topics such as, patient involvement in drug development, benefit-risk assessment or accelerated approval pathways. During the course, the students will also be introduced to both qualitative and as quantitative research methods in regulatory science. 

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

  • 3 days during week 47 (19-23 November) 2018

Application deadline

  • 24 September 2018

Exam dates

  • Submission of written assignment by 3 December at 14:00

Course fee

EU/EEA citizens Non EU/EEA citizens
Master student DKK 10.000 DKK 11.500
Single course student DKK 12.000 DKK 13.500