Regulatory affairs

Theoretical and practical aspects


Our regulatory affairs courses provide you with up-to-date, in-depth knowledge of the most important theoretical and practical aspects of regulatory issues related to pharmaceutical and biopharmaceutical products. You can take individual courses or participate in a flexible, part-time postgraduate programme.  With the postgraduate programme, you will gain an understanding of the entire ‘regulatory affairs platform’ of the medicinal product lifecycle – from molecule to marketing authorisation and maintenance.


Individual regulatory affairs courses focus on the European Regulatory Affairs environment, but also touch on the US, Japan and other relevant countries within the ICH, as well as the major markets outside the ICH. We also offer specific courses on the regulatory affairs environment in the US, Japan, major markets outside the ICH (such as BRIC and MENA countries), medical devices and veterinary regulatory affairs in the EU.

Our diploma modules require a minimum of 2 years of experience in regulatory affairs or another relevant area, or experience in the pharmaceutical/biological area that qualifies you to benefit from the training. We consider applicants with less than two years of experience on a case-by-case basis.

Introductory courses:

Introduction to Regulatory Affairs - Read more

Diploma and Master modules - can be taken as individual modules:

The Pharmaceutical Law Frameworks in the EU (Module 1) - Read more
Procedures and Applications in the EU (Module 2) - Read more
The US Regulatory Environment (Module 3) - Read more
The Regulatory Affairs Environment in Japan (Module 4) - Read more
Global Regulatory Strategies (Module 5) - Read more
Quality - Drug Substance and Drug Product (Module 6) - Read more
Non-clinical Development and Documentation (Module 7) - Read more
Clinical Development and Documentation (Module 8) - Read more
Product Life Cycle Activities (Module 9) - Read more
Biopharmaceuticals - Quality Development and Documentation (Module 10) - Read more
Drug/Device Combination Products (Module 12) - Read more 
The Regulatory Affairs Environment for Generic Products in the EU (Module 15) - Read more

regulatory affairs certification

Through our regulatory affairs department, you can design your own Master’s Degree or diploma. You can attend individual courses in random order in a way that suits your home or work life. To earn regulatory affairs certification and the Diploma in Regulatory Affairs, you must pass eight courses, one of which may include a course from the pharmacovigilance programme.

To learn more about the Master of Medicines Regulatory Affairs and our collaboration with University of Copenhagen, please visit


Our courses have been developed as a collaboration between a team of internationally renowned regulatory affairs experts from the pharmaceutical and biotech industries, the Danish Medicines Agency and researchers from the Faculty of Pharmaceutical Sciences, University of Copenhagen. Through their representation in the Steering Committee and as frequent course leaders and lecturers in the individual modules, all these experts are involved in the continuous development of the programme.


The faculty comprises international experts from the pharmaceutical and biotech industries, authorities and universities.

Learning activities include class teaching, self-studies, interactive discussions, case studies and workshops. Each course is concluded with an examination approximately 4 weeks after the course.


Gitte Dyhr, Senior Director, Head of Labelling Committee, Regulatory Affairs, H. Lundbeck A/S
Joan Boye, Head of Section, Danish Medicines Agency
Sven Frøkjær, Vice-Dean, Professor, University of Copenhagen
Nina Christiansen, Senior Director, Regulatory Market Excellence, LEO Pharma A/S
Anne Lützhøft Aarbogh, Vice President Global Regulatory Affairs, ALK-Abelló A/S
Vibeke Hatorp, Senior Director, Regulatory Affairs, Novo Nordisk A/S
Birgitte Houmøller Veng, Head of Compliance, Nordics and Baltics, Commercial Operations, Takeda Phama A/S
Ann Christine Korsgaard, CEO, Biotrack ApS
Marianne Toft, Global Leader, Life Science, Strategic Changes and Organisational Development, LEO Pharma A/S
Katja Gustafsson, Associate Director Regulatory Affairs, Ferring Pharmaceuticals A/S
Kirsten Junker, Head of Regulatory Affairs, Pfizer ApS
Eva Gamwell Henriksen, Director, Regulatory Affairs, Ascendis Pharma A/S
Margit Andreasen, Technical and Regulatory Affairs, Danish Association of the Veterinary Pharmaceutical Industry (VIF)