External Lecturer, Department of Pharmacy, University of Copenhagen and Regulatory Affairs senior RA CMC specialist
Nykode Therapeutics.
The EU Regulatory Environment - Procedures and Applications
This course addresses the current and practical aspects of getting medicines approved in the EU.
This course is a part of
Understand 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.
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 in the EU, i.e. what is required of an marketing authorisation application.
Course content
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.
The lectures will be held by leading experts from industry and from health authorities. The theoretical exercises will be held as group work exercises where both procedural as well as strategic aspects will be discussed.
Course Directors on The EU Regulatory Environment - Procedures and Applications
Eva Maiken Holck
Course details for The EU Regulatory Environment - Procedures and Applications
Dates and examination
Course dates
4 - 6 March 2026
The course is available every second year.
Examination
Please find the exam dates in the exam plan.
You can find further information about the course and the exam in the course curriculum.
See an overview of all courses on Master of Medicines Regulatory Affairs.
Learning outcomes
This course will give you the ability to 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.
You will also be able to explain and discuss:
- the Centralised Procedure (CP),
- the Mutual Recognition Procedure/Decentralised Procedure (MRP/DCP),
- the needed content for clinical trial application,
- the procedures for obtaining scientific advice,
- the orphan medicinal product designation,
- the content of risk management plans, and
- the content and timing of the paediatric investigation plans.
Throughout the course, you will be taught to analyse the overall strategic choices for the regulatory procedure used during development, application and maintenance of the medical product.
After the course, you will be able to make strategic plan for applying for an MA and provide/obtain the needed documentation.
Admission criteria
Regulatory affairs specialists striving to innovate and strengthen the regulatory process
The course is intended for regulatory affairs specialists employed in industry, regulatory agencies or consulting.
You must meet the following criteria to be admitted to this course:
- Hold a relevant bachelor degree or equivalent
- Have a minimum 2 years of relevant job experience
- Be proficient in English
Find detailed information in the admission criteria on Master of Medicines Regulatory Affairs.
You will receive a response to your application at the earliest on 1 May and no later than 2 weeks after the application deadline.
Priority is given to enrolled students
This course is offered as a compulsory course in the Master of Medicines Regulatory Affairs programme. Priority is given to students already enrolled. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Partnership with Atrium
Atrium is a partner of Master of Medicines Regulatory Affairs. This course is one of 5 courses at the Master's programme, which are offered in collaboration with Atrium.
Atrium is one of Europe’s leading private course providers of practice-based courses in Regulatory Affairs. Their courses are based on collaboration with academia, industry experts and representatives from healthcare authorities.
International educational academy
Atrium is an international educational academy established by The Danish Association of the Pharmaceutical Industry (Lif). As a part of the Danish Association of the Pharmaceutical Industries, Atrium has a close connection to the experts in the Pharmaceutical Industry.
Tuition fees
EU/EEA citizens
Master student: 21,401 DKK
Single course: 23,401 DKK
Non-EU/EEA citizens
Master student: 23,801 DKK
Single course: 25,801 DKK
The fee includes lunch/coffee.
Place
Atrium
Lersø Parkallé 101
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
Tel.: +45 35 33 60 66