1 September 2024

Drug Regulatory Affairs in Drug Development

Understand the role of regulatory affairs in the drug development process, in particular the requirements regarding quality, safety and efficacy.


Knowing how to focus the development process in regards to regulatory affairs and co-operate with the regulatory affairs professionals can be vital for the success of a medicinal product and the survival of a pharmaceutical company.

All aspects within the pharmaceutical development process of medicinal products are subject to various degree of regulation. The pharmaceutical law frame, guidelines, Health Authorities' attitudes and requirements have a significant influence on the drug development process and its success rate.

This course is designed to give you the necessary basic background to understand and incorporate drug regulatory affairs in the drug development process. 












Upon completion of the course you will have an extensive overview and understanding of the drug regulatory affairs in drug development and be able to:

  • Understand the role of regulatory affairs in the drug development process, particularly in respect of requirements to quality, safety and efficacy
  • Understand the law frame and guidelines within regulatory affairs
  • Discuss the law frame and guidelines within regulatory affairs
  • Understand, interpret and follow regulatory guidelines
  • Apply knowledge of regulatory affairs in your daily work
  • Recognize the different types of applications and application procedures available in the EU, US and outside EU/US






































Course details

Duration: 5 days on campus
Dates: Expected to be offered in autumn 2024 semester
Frequency: Only available every second year
Place: University of Copenhagen, Copenhagen, Denmark
Course fee:

EU/EEA citizens: 10,750 DKK
Non-EU/EEA citizens: 12,488 DKK

The fee includes lunch/coffee.

Payment conditions

Level and credit: Master course; 2,5 ECTS
Examination date: Please consult the exam schedule
Application deadline: 8 weeks prior to course start

To be admitted, you must meet the admission criteria for Master of Industrial Drug Development

Download course curriculum
Course dates and application deadlines are announced via the  programme newsletter.