Drug Regulatory Affairs in Drug Development

The contents will cover the role and responsibility for the drug regulatory affairs professionals – how they are involved in the development process, how to co-operate with this function, the pharmaceutical law frame in EU, US and outside EU/US, the application and approval procedures, regulatory strategic issue, how to build up an application for a marketing authorization, variations, incentives, pharmacovigilance, and how to approach the issues of Quality, Safety and Efficacy from a regulatory point of view.

The faculty of the course includes a series of experts both from regulatory affairs departments in industry and from the regulatory authorities. In this way the students will receive detailed information from people with hands-on experience in regulatory affairs in their daily work.

The course participants include people from different companies and institutions and with a variety of professional roles. This facilitates the lively discussions during the lectures and even during the breaks.

Upon completion of the course you will have an extensive overview and understanding of the drug regulatory affairs in drug development and be able to:

• Understand the role of regulatory affairs in the drug development process, particularly in respect of requirements to quality, safety and efficacy
• Understand the law frame and guidelines within regulatory affairs
• Discuss the law frame and guidelines within regulatory affairs
• Understand, interpret and follow regulatory guidelines
• Apply knowledge of regulatory affairs in your daily work
• Recognize the different types of applications and application procedures available in the EU, US and outside EU/US

Professionals in need of interdisciplinary overview

This course is designed to give you the necessary basic background to understand and incorporate drug regulatory affairs in the drug development process. 

Participants must

• Hold a relevant bachelor degree or equivalent
• Have a minimum 2 years of relevant job experience in drug development
• Be proficient in English

Find detailed information about the admission criteria.

Course responsible
Associate professor Lene Jørgensen, Department of Pharmacy, University of Copenhagen

Visiting experts from the pharmaceutical industry
Nina Christiansen, LEO Pharma
Gitte Dyhr, H. Lundbeck
Kristina Bech Jensen, Danish Health and Medicines Authority
Hanne Arntsen, LEO Pharma
Anette Hjelmsmark, Novo Nordisk
Merete Schmigelow, Novo Nordisk
Lise Johansen, Novo Nordisk
Nanna Aabye Kruuse, Danish Health and Medicines Authority
Karen Fich, H. Lundbeck
Jens Thing Mortensen, Genmab
Doris Stenver, Danish Health and Medicines Authority

This course is offered as an compulsory course in the Master of Industrial Drug Development programme.

Priority is given to students enrolled on Master of Industrial Drug Development. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.