Foundation Course: Regulatory Affairs

Event Details

This 3-days course is for you who need a broad and essential knowledge of Regulatory Affairs. In September 2017 the participants gave the course a rating of 4.5 out of 5!


Who should attend

The course aims primarily at you who are new in your role within Regulatory Affairs and need knowledge about current regulations, processing and documentation. This course is also suitable for you who have worked for a while within the area and want an update or confirm your knowledge and get an opportunity to exchange experiences with colleagues regarding practical application of current regulations and guidelines.


Learning objectives

This is a foundation course that gives a comprehensive picture of Regulatory Affairs. After the course, you will have broad knowledge of Regulatory Affairs and a platform for further development in the field.



Course outline

The course is structured around lectures and discussions – individually and in groups. Participants are given the opportunity to submit questions prior to the course starting date. From the program:


  • Regulations
  • The role of the authorities in Regulatory affairs
  • Regulatory Affairs Role in pharmaceutical development
  • Development phases from selection of substance to completed market authorization approval
  • Market authorization application: structure and content
  • Application documentation in electronic format
  • Product information
  • Practical application and discussions


All lecturers have long experience from Regulatory Affairs in the pharmaceutical industry and/or authority.

Price starting from 15.300 SEK


Registration: Please contact Jenny Hagberg at:

Questions: Please contact Ania Johansen at:


Oslo Cancer Cluster will be collaborating with the Swedish Academy of Pharmaceutical Sciences (SAPS) and Innovation Norway, to offer you educational courses of high quality in different fields related to drug development. The courses will be held in Stockholm, but will be live streamed to OCC Incubator with a moderator and with interactive functions to participate in the course. Refreshments and lunch is also included.

The aim for the live streaming is to create an attractive, cost- and time effective alternative based upon these educational courses. The audience will be a smaller/medium sized group, which will have the possibility to discuss and share between them, as well as asking questions to the lecturers in real time. The entire course will also be available to all participants for 30 days, through a video of the stream and the slides used.