Regulatory affairs

Theoretical and practical aspects

FROM MOLECULE TO MARKETING AUTHORISATION AND MAINTENANCE

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.

FOCUSED COURSES

Individual 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.

Experience:
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

Basic regulatory Aspects of Clinical Development

Diploma and Master modules - can be taken as individual modules:
The Pharmaceutical Law Frameworks in the EU (Module 1)

Procedures and Applications in the EU (Module 2)
The Regulatory Affair Environment in the USA (Module 3)
The Regulatory Affair Environment in Japan (Module 4)
Global Regulatory Strategies (Module 5)
Quality - Drug Substance and Drug Product (Module 6)
Non-clinical Development and Documentation (Module 7)
Clinical Development and Documentation (Module 8)
Product Life Cycle Activities (Module 9)
Biopharmaceuticals - Quality Development and Documentation (Module 10)
Medical Devices - Drug/Device Combinations (Module 12)
Veterinary Regulatory Affairs in the EU (Module 14)
The Regulatory Affairs Environment for Generic Products in the EU (Module 15)

DESIGN YOUR OWN PROGRAMME

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 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 http://mra.ku.dk/

DEVELOPED BY

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.

FACULTY

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.

FACULTY BOARD MEMBERS

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)

  

Want to know more?

Contact Senior Programme Director Tina Jensen at +45 39 15 09 14

Send an email