Danish Health and Medicines Authority
Drug Regulatory Affairs in Drug Development
Understand the role of regulatory affairs in the drug development process, in particular the requirements regarding quality, safety and efficacy.
This course is a part of
This course is designed to give you the necessary basic background to understand and incorporate drug regulatory affairs in the drug development process.
Knowing how to focus the development process in regards to regulatory affairs and co-operate with the regulatory affairs professionals can be vital for the success of a medicinal product and the survival of a pharmaceutical company.
All aspects within the pharmaceutical development process of medicinal products are subject to various degree of regulation. The pharmaceutical law frame, guidelines, Health Authorities' attitudes and requirements have a significant influence on the drug development process and its success rate.
This course is designed to give you the necessary basic background to understand and incorporate drug regulatory affairs in the drug development process.
Course content
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.
For more details about the course, please refer to the course curriculum.
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I highly recommend the course "Drug Regulatory Affairs in Drug Development", especially if a person has at least a few years of experience in regulatory. The course provides an overall regulatory strategy and intelligence based on real cases, as well as a high-level regulatory overview of drug approvals in the main regions/countries. You will receive systematic and well-structured answers and clues to what you have been wondering about in your job.
Course directors on »Drug Regulatory Affairs in Drug Development«
Course details for »Drug Regulatory Affairs in Drug Development«
Dates and examination
Course dates
The next course is scheduled for spring 2026. Exact dates will follow.
The course is available every other year.
Examination
Please find the exam dates in the exam plan.
Learning outcomes
Upon completion of the course, you will be able to:
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understand the role of regulatory affairs in the drug development process, particularly in respect of requirements to quality, safety and efficacy
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understand the law frame and guidelines within regulatory affairs
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discuss the law frame and guidelines within regulatory affairs
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understand, interpret and follow regulatory guidelines
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apply knowledge of regulatory affairs in your daily work
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recognize the different types of applications and application procedures available in the EU, US and outside EU/US.
Admission criteria
You must meet the following criteria to be admitted to this course:
- 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 in the admission criteria on Master of Industrial Drug Development.
Priority is given to enrolled students
This course is offered as a compulsory course in the Master of Industrial Drug Development programme. Priority is given to students already enrolled. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Tuition fees
EU/EEA citizens
12,050 DKK
Non-EU/EEA citizens
13,825 DKK
The fee includes lunch and coffee.
More information
All course information is available in the course curriculum:Place
University of Copenhagen
Department of Pharmacy/
Department of Drug Design and Pharmacology
Universitetsparken 2
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
master@sund.ku.dk
Tel: +45 35 33 60 66