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 regulatory affairs courses focus on the European Regulatory Affairs environment, but also touch on the US and other relevant countries within 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


Diploma and Master modules - can be taken as individual modules

The Pharmaceutical Law Frameworks in the EU (Module 1)

The EU Regulatory Environment - Procedures and Applications (Module 2)

The US Regulatory Environment (Module 3)

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)

Drug/Device Combination Products (Module 12)

The Regulatory Affairs Environment for Generic Products in the EU (Module 15)

Regulatory affairs certification

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 regulatory affairs certification and the Diploma in Regulatory Affairs, you must pass eight courses, one of which may include a course from the Diploma in Pharmacovigilance.

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.

Advisory Board

At Atrium we believe it is of the utmost importance that stakeholders from the entire Life Science sector, being in contact with clinical research one way or another, also represent Atrium’s professional anchor. Here you can see the members of our Regulatory Affairs advisory board:


Gitte Dyhr, Senior Director, Head of Labelling Committee, Regulatory Affairs, H. Lundbeck A/S

Jens Heisterberg, VP Regulatory Intelligence, Novo Nordisk A/S

Anne Lutzhøft Aarbogh, Senior Vice President, Global Regulatory Affairs, ALK-Abellò

Lene Jørgensen, Associate Professor, University of Copenhagen

Helen Shennan, Head of Regulatory Affairs, AstraZeneca A/Sb

Jakob Bjerg Larsen, Head of Clinical Trials and Pharmaceutical Manufacturing Policy, LIF

Sarah Mangor, Regulatory Lead Nordics, Haleon

Christine Erikstrup Hallgreen, Associated Professor, University of Copenhagen

Rikke Bradstrup Haladyn, Senior Regulatory Science Specialist, IWA Consulting ApS

Maiken Gy Kongstad, VP, Global Regulatory Affairs, LEO Pharma

Christina Balslev Rindshøj, VP - Head of Regulatory Affairs, ZealandPharma

Sysser Agergaard Ærtebjerg, Managing Director, Atrium

Mette Ribergaard Rasmussen, Client Manager, Atrium

Lone Rex, Educational Programme Leader, Atrium



What is Regulatory Affairs?


Regulatory Affairs (RA) is an independent function in most life science companies. RA ensures regulatory approval of a medicinal product, including dialogue with authorities from the early development phase to approval, further product development, and maintenance.

RA collaborates across disciplines with colleagues from Research and Development, Product Development and Supply, Clinical Development, Medical Affairs, Patents and Trademarks, Market Access, and Marketing and Sales. An RA manager is a strategic advisor and must understand and interpret authority requirements as well as understand the data generated in clinical development. An RA professional typically comes from a healthcare scientific background.

RA is gaining increasing strategic importance, as new and stricter pharmaceutical regulation is continually implemented. Therefore, employees with a good understanding of the activities and processes associated with bringing medicines on the market are sought-after.


Want to know more?

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

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