SUMMARY
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.
Keywords
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.
Prerequisites
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.
Examination
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.
Next course:
9 Apr 2025