Summary
This three-day course gives you practical insight into pharmaceutical legislation in the EU. You will gain a clear overview and a deeper understanding of the EU’s legislative and regulatory framework that governs the development and authorisation of medicinal products.
You'll explore the roles and responsibilities of key stakeholders in the EU regulatory process and understand how institutions such as the European Medicines Agency (EMA) and National Competent Authorities (NCAs) work together.
We take a hands-on approach with group work, focusing on the practical steps of marketing authorisation applications and orphan drug designation applications in the EU. You will also learn how to comply with EU requirements related to pediatric investigation plans and pharmacovigilance, plus how to obtain scientific advice from EU authorities.
These insights will give you the confidence to navigate the regulatory framework governing medicinal product development in the EU.
Keywords
- The EU legislative and regulatory framework
- Marketing Authorisation Applications
- Pediatric Investigation Plans
- Orphan medicines
- Scientific advice
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Course leader & lecturers
- Sanne HaveCourse leaderChefkonsulent
Lægemiddelstyrelsen - Mette Due Theilade ThomsenCourse leaderManaging Director
PIP Adviser
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Is this course for you?
The course is designed for regulatory professionals working in the life science sector, regulatory authorities or consultancy firms. If you are a legal professional working in the life science industry, this course offers a solid introduction to the regulatory landscape. It is recommended that participants have at least two years of relevant work experience.
What you will learn
- To understand the regulatory framework in the EU and navigate the different types of applications and procedures
- To evaluate the opportunities and implications for different product types and applications
- To analyse strategic choices around regulatory procedures during the development and approval of the drug
- To apply best practices when managing applications and procedures in cooperation with European authorities
What your company will get
- A regulatory professional who understands and can navigate different application procedures within the EU framework
- A regulatory professional who can evaluate and analyse the strategic choices for different types of applications
- A regulatory professional who can contribute valuable input to regulatory procedures during the development and authorization process
- A regulatory professional who can take on an important strategic role in any project team working towards obtaining EU marketing authorisation.
Course calendar
Day 1
- Soon to come
Day 2
- Soon to come
Day 3
- Soon to come
Registration
Registration deadline3 Nov 2026
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Before the course, you will get access to mandatory and/or supplementary reading materials through your personal Atrium login.
Examination
The exam is held online, approximately 4-6 weeks after the course.
You will receive a link to the exam questions via your personal Atrium login.
To be eligible for the exam, you must have attended the course.
Course leaders
Lægemiddelstyrelsen
PIP Adviser
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Want to know more or need help?
Contact Client Manager Mette Ribergaard Rasmussen at +45 39 27 60 60
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