Diploma in Regulatory Affairs

Theoretical and practical aspects


Our Diploma in Regulatory Affairs provides 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 gain an understanding of the entire regulatory affairs platform of the medicinal product lifecycle from the molecule stage to marketing authorisation and maintenance.


Design your own diploma

You can design your own Diploma in Regulatory Affairs by attending individual courses from our regulatory affairs selection in whichever order you like. To earn the Diploma in Regulatory Affairs, you must attend and pass the exams of six courses within a six-year period, one of which can be a pharmacovigilance course .

Our courses offer a mixture of learning activities including classroom teaching, self-study, interactive discussions, case studies, and workshops. We conclude each course with an examination approximately four weeks after the end of each course.

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 at the University of Copenhagen. Through their representation in our Advisory Board and as frequent course leaders and lecturers at the individual courses, all these experts are involved in the continuous development of our courses.

This is what course participants say 

“The knowledge gained on the courses has – on top of my daily on-the-job learning – helped me develop skills and competences more easily and quicker and has thereby created new opportunities in my career”,

Bettina Lindharth Madsen, Principal Regulatory Affairs Professional at ALK Abelló.

“Picking up new knowledge and getting the ‘big picture’ had a very positive impact on my job satisfaction. Over the years it has been an important asset in my career moves and has definitely helped me pursue my job aspirations”,

Anders Gerner Petersen, Head of Regulatory Affairs at Merck Group.


Regulatory Affairs in the EU, USA and Japan
Pharmaceutical Law Frameworks
Marketing Authorizations
Good Regulatory Practice
Global Drug Development

Target group

The Diploma in Regulatory Affairs is relevant if you are an experienced regulatory affairs professional who wants to improve your knowledge and skills. You may be employed in the pharma industry, a regulatory agency, or a consulting firm.


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


The exam is held online, usually 4-6 weeks after each course. You will receive a link with exam questions via your personal Atrium log-in. In order to participate in the exam, you must have attended the course. 

Want to learn what it takes to complete the Regulatory Affairs Diploma?

Learn why you should do it, and what will get you through by watching the video below. 

You deserve to be celebrated!

We are excited every time one of our course participants completes a diploma: You've made a significant investment in yourself, and that deserves recognition. That's why we host a diploma ceremony twice a year. You can find available dates and register here. At the event, you'll receive your diploma, and we'll provide some refreshments. Feel free to bring your family along.

Should you prefer to receive you diploma via mail, this is, of course, also possible.

Regulatory Affairs Modules

The Pharmaceutical Legal Frameworks in the EU, module 1
Next course: 9 Apr 2025
The EU Regulatory Environment - Procedures and Applications, module 2
Next course: 24 Sep 2024
The US Regulatory Environment, module 3
Next course: TBD
The Regulatory Affairs Environment in Japan, module 4
Next course: TBD
Global Regulatory Strategies, module 5
Next course: 22 May 2024
Quality - Drug Substance and Drug Product, module 6
Next course: 7 Oct 2024
Non-Clinical Development and Documentation, module 7
Next course: TBD
Clinical Development and Documentation, module 8
Next course: 29 Oct 2024
Product Life Cycle Activities, module 9
Next course: TBD
Biopharmaceuticals - Quality Development and Documentation, module 10
Next course: 25 Nov 2024
Medical Devices - Drug/Device Combinations, module 12
Next course: TBD
Veterinary Regulatory Affairs in the EU
Next course: TBD
The Regulatory Affairs Environment for Generic Products in the EU, module 15
Next course: 4 Feb 2025

Registration quick facts

How do I pay for a course?

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

I have problems getting my order through. Can I get assistance?

Yes, if you experience any technical problems, please call us at + 45 39 27 60 60, or send us an email at contact@atriumcph.com

What if I get sick and can’t attend?

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick and cannot attend the course, you may hand over the seat to a colleague, who will then have to register for the course on our website prior to course start. If the registration is closed, please send us full name, email, phone and title of your colleague to bfl@atriumcph.comRead our cancellation policy.

Want to know more about this course?

Contact Client Manager Mette Ribergaard Rasmussen at +45 39 15 09 30

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