Summary
This two day course will provide you with a solid basis for evaluating the opportunities and consequences related to different types of products and submissions. It will also teach you how to plan and operate within the framework of the various application procedures.
While Module 1, "The Pharmaceutical Law Frameworks in the EU", provides you with knowledge of the pharmaceutical legislation in the EU, Module 2 focuses on the implementation of this legislation, e.g., on the procedural and operational aspects when applying for marketing authorizations, clinical trials and orphan drug designations in the EU. You will also learn how to comply with the EU requirements for pediatric investigation plans and risk management plans as well as how to obtain scientific advice from EU authorities.
Other course participants say
“Course content, speakers and organisation met my expectations, in some cases even exceeded them. I highly recommend this course".
Dr. Kristina Mueller, Preclinical Expert.
"I appreciated getting the general overview of European issues in a structured manner - and then presented by knowledgeable and experienced lectures. It was directly applicable, but also useful for more general discussions in and around Regulatory Affairs."
Rasmus Ploug Winchler Larsen, Senior Manager, RA CMC Biologics, LEO Pharma A/S
Keywords
- Regulatory Affairs in the EU
- Marketing Authorization Applications
- Scientific Advice
- Post-Approval Activities
- Pediatric Procedures
- Clinical Trials Applications
- Risk Management
- Orphan Medicinal Products
Please note
As this module is a mandatory module in the Master of Medicines Regulatory Affairs at the University of Copenhagen you will apply via the joint Atrium and University of Copenhagen application form. This means that you will be enrolled at both Atrium and the University of Copenhagen and that your data will be registered at both institutions. If you are not enrolled as a master student, you will be registered as a single course student at the University of Copenhagen.
Course fee includes examination. By default you will pay the full amount to the University of Copenhagen regardless of you taking the exam or not. If you decide not to take the exam, you can apply for a refund of the exam fee at Atrium by contacting Atrium - please see contact details below. You must apply for a refund no later than two weeks after completion of the course.
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Course leader & lecturers
- Eva Maiken HolckCourse leaderRegulatory Affairs senior RA CMC specialist
Nykode Therapeutics Denmark A/S - Mette Due Theilade ThomsenCourse leaderManaging Director
PIP Adviser
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Is this course for you?
This course is for you if you work as a regulatory affairs specialist, employed in the industry, a regulatory agency, or a consulting firm.
You must have a minimum of 2 years relevant job experience.
What you will learn
- To understand the EU regulatory framework and the various types of applications and procedures
- How to evaluate the opportunities and consequences related to different types of products and submissions
- How to analyze the overall strategic choices for the regulatory procedures used during development, application, and maintenance of the medicinal product
- How to use best practices when handling various applications and procedures as well as when interacting with the European Authorities
What your company will get
- A regulatory professional who understands and can operate within the framework of the various application procedures in the EU
- A regulatory professional who can evaluate and analyze the strategic choices related to different types of submissions
- A regulatory professional who can provide valuable input to the regulatory procedures used during the development, application, and maintenance of the medicinal product
- An employee who can play an important strategic role in any project team working on obtaining a marketing authorization in the EU
Course calendar
Day 1
- Marketing Authorisation Applications – Overview, Terminology and Organisation
- The Centralised Procedure – EMA Perspective
- The Centralised Procedure - Examples of a discussion in CHMP
- Group work
- Scientific advice from CHMP and national competent authorities
- Group work
- Networking with tapas
Day 2
- Summary of day 1 and introduction to day 2
- New applications in the decentralized/mutual recognition procedure (incl. break)
- Orphan medicinal products
- Group work
- Clinical trial applications in a Pan-European view
- Referrals
- Group work
Day 3
Summary of day 2 and introduction to day 3
Paediatrics – procedural perspective
Post-approval activities
Health technology assessment – HTA
Risk Management
Group work
Wrap-up and goodbye
Registration
Registration deadline21 Jan 2026
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarize yourself with the mandatory readings before starting the course.
The mandatory readings are also part of the examination syllabus.
Prerequisites
To enroll in this course, you must have a relevant educational background at bachelor level and, as a minimum, two years of experience in regulatory affairs, or other equivalent qualifications. We consider all applications upon registration.
If you do not fulfill the requirements, you can still apply for the course if you have experience in the pharmaceutical/biological area that would allow you to benefit from the training and enable you to participate actively during the module. Up to 20% of the positions on our course are filled by applicants who have no or limited experience in regulatory affairs. We consider applicants on a case-by-case basis.
Examination
The exam is usually held 4-6 weeks after the course.
It is a digital exam in the University of Copenhagen’s digital exam system.
This course is a part of a diploma
Are you a Regulatory Affairs professional and are you concerned with your ongoing learning and development? Consider these courses, offered in together with University of Copenhagen. Explore the Master of Medicines Regulatory Affairs (MRA).
Read moreDiploma in Regulatory Affairs
The regulatory affairs diploma gives you an understanding of the entire regulatory affairs platform of the medicinal lifecycle. All courses have been designed in collaboration with highly acclaimed experts that are on our regulatory affairs Advisory Board.
Read moreCourse leaders
Nykode Therapeutics Denmark A/S
PIP Adviser
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