Regulatory Affairs Diploma

Theoretical and practical aspects

8 courses

Diploma

English

From
129.300,- DKK ex VAT
(app. 17.384,- EUR ex VAT)

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 t he world.

Modules
Product Life Cycle Activities
Get an understanding of the basic regulatory requirements for a pharmaceutical product in the post-approval phase
The Pharmaceutical Law Frameworks in the EU
Understand the pharmaceutical law frameworks and how legislation is developed in the EU
Biopharmaceuticals - Quality Development and Documentation
Get an understanding of the quality issues specific to biopharmaceuticals
Medical Devices - Drug/Device Combinations
Learn about regulatory affairs within medical devices and drug/device combinations
Procedures and Applications in the EU
EU Applications for Marketing Authorizations, Pediatric Investigation Plans, Clinical Trials and Orphan Drug Designation
The Regulatory Affair Environment in the USA
Understand how to best develop and gain approval for a new drug or biologic in the USA
The Regulatory Affair Environment in Japan
Understand how to successfully navigate the Japanese health authorities and bring pharmaceutical products onto the Japanese market.
Global Regulatory Strategies
Regulatory strategic considerations during global drug development and good regulatory practice
Quality - Drug Substance and Drug Product
Get an overview of the quality-related requirements of the quality part of the dossier
Non-clinical Development and Documentation
Get an overview of the requirements and critical issues of non-clinical studies
Clinical Development and Documentation
Gain a comprehensive overview of the regulatory aspects of global clinical development processes and the documentation needed for the clinical sections of the Common Technical Document (CTD)

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