The EU Regulatory Environment - Procedures and Applications – University of Copenhagen

Master of Medicines Regulatory Affairs > Courses > The EU Regulatory Envi...

The EU Regulatory Environment - Procedures and Applications

This course addresses the current and practical aspects of getting medicines approved in the EU. The student will obtain knowledge of the EU pharmaceutical legislation, the content of a marketing authorisation application (MAA), EU approval procedures, scientific advice from CHMP and national authorities, paediatric investigation plan, and orphan products, and Risk Management Plans.
After completion the student will be able to navigate in the approval procedures and
requirements for medicines in the EU, seek scientific advice from authorities and suggest and discuss reasonable pathways for obtaining approval for medicines (i.e. what is required of an MAA) in the EU.

What do you gain?


  • Explain and discuss the EU regulatory framework and the various types of marketing authorisation applications (MAAs) for new medicinal products, generic and similar biological medicinal products, line extensions, variation applications and renewals
  • Explain and discuss the Centralised Procedure (CP) and the Mutual Recognition Procedure /
  • Decentralised Procedure (MRP/DCP)
  • Explain and discuss the needed content for a clinical trial application
  • Explain and discuss the procedures for obtaining scientific advice
  • Explain and discuss the orphan medicinal product designation
  • Explain and discuss content and timing of the paediatric investigation plans
  • Explain and discuss the content of risk management plans


  • Analyse and consider the requirements for a MAA
  • Identify, analyse and consider regulatory opportunities and consequences related to different types of products and submissions e.g. orphan medical products
  • Comply with the EU requirement for paediatric investigation plans and risk management plans
  • Analyse the overall strategic choices for the regulatory procedure used during development, application and maintenance of the medical product


  • Make strategic plans for applying for an MA and provide/obtain the needed documentation.

Course dates

  •  3-5 September 2018

Application deadline

  • 6 August 2018

Applications will be processed by receipt, and applicants are admitted on a "first come, first served" basis. Registration will close when the maximum number of seats are taken. Applicants will be notified of admission within 4 weeks of submitted application. Please note that the course can be cancel or rescheduled if the number of participants fails to meet the required minimum.

Exam date

  •  3 October 2018 (online)

Course fee

EU/EEA citizens

Non EU/EEA citizens
Master student DKK 17.975 DKK 19.975
Single course student DKK 19.975 DKK 22.000