Regulatory Affairs Diploma

Theoretical and practical aspects

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 will gain an understanding of the entire ‘regulatory affairs platform’ of the medicinal product lifecycle from the molecule stage to marketing authorization and maintenance.

You can design your own diploma by attending individual courses in whichever order you like. To earn the Diploma in Regulatory Affairs, you must attend and pass the exams of eight courses, one of which can be from the pharmacovigilance programme. 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 the Steering Committee and as frequent course leaders and lecturers in the individual modules, all these experts are involved in the continuous development of our programme. Read more about our regulatory affairs faculty board.

Keywords

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

Target group

Whether you are new to the field or have several years of experience, this programme is relevant if you are a regulatory affairs professional who wants to improve your knowledge and skills.

Prerequisites

Our diploma modules 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

We conclude each course with an examination approximately four weeks after the end of each course. The exam consists of essay assignments and multiple-choice questions covering the exam syllabus. You can bring notes and books to the exam, but please note that you are not allowed to use the internet.

Please let us know if you would like to sit the exam in your own country as we can arrange examinations at embassies, universities, etc., all over the world.

DESIGN YOUR OWN DIPLOMA 

See all regulatory affairs courses below and select the ones that are relevant for you. To earn the Diploma in Regulatory Affairs, you must attend and pass the exams of eight courses, one of which can be from the pharmacovigilance programme. Go to the Pharmacovigilance Programme.

Regulatory Affairs Modules
The Pharmaceutical Law Frameworks in the EU
The EU Regulatory Environment - Procedures and Applications
The Regulatory Affair Environment in the USA
The Regulatory Affair Environment in Japan
Global Regulatory Strategies
Quality - Drug Substance and Drug Product
Non-clinical Development and Documentation
Clinical Development and Documentation
Product Life Cycle Activities
Biopharmaceuticals - Quality Development and Documentation
Medical Devices - Drug/Device Combinations
Veterinary Regulatory Affairs in the EU
The Regulatory Affairs Environment for Generic Products in the EU

Registration quick facts

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.

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

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick on the day of the course, you can hand over your seat to a colleague. To hand over your seat, please contact us at +45 39 27 60 60. Read our cancellation policy.

WANT TO KNOW MORE ABOUT THIS PROGRAMME?

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

Send an email