The EU Regulatory Environment - Procedures and Applications
Understand the EU regulatory framework and the various types of marketing authorisation applications (MAAs) for new medicinal products, generic and similar biological medicinal products, line extensions, variation applications and renewals.
This course addresses the current and practical aspects of getting medicines approved in the EU.
After completion the student will be able to navigate in the approval procedures and requirements for medicines in the EU, seek scientific advice from authorities and suggest and discuss reasonable pathways for obtaining approval for medicines in the EU, i.e. what is required of an marketing authorisation application.
The student will obtain knowledge of the EU pharmaceutical legislation, the content of a marketing authorisation application (MAA), EU approval procedures, scientific advice from CHMP and national authorities, paediatric investigation plan, and orphan products, and Risk Management Plans.
The lectures will be held by leading experts from industry and from health authorities. The theoretical exercises will be held as group work exercises where both procedural as well as strategic aspects will be discussed.
This course will give you the ability to explain and discuss the EU regulatory framework and the various types of marketing authorisation applications (MAAs) for new medicinal products, generic and similar biological medicinal products, line extensions, variation applications and renewals.
You will also be able to explain and discuss:
- the Centralised Procedure (CP),
- the Mutual Recognition Procedure/Decentralised Procedure (MRP/DCP),
- the needed content for clinical trial application,
- the procedures for obtaining scientific advice,
- the orphan medicinal product designation,
- the content of risk management plans, and
- the content and timing of the paediatric investigation plans.
Throughout the course, you will be taught to analyse the overall strategic choices for the regulatory procedure used during development, application and maintenance of the medical product.
After the course, you will be able to make strategic plan for applying for an MA and provide/obtain the needed documentation.
Innovate and strengthen the regulatory process
The course is intended for regulatory affairs specialist employed in industry, regulatory agencies or consulting.
- Hold a relevant bachelor degree or equivalent
- Have a minimum 2 years of relevant job experience
- Be proficient in English
Find detailed information about the admission criteria.
- Eva Maiken Holck, External Lecturer, Department of Pharmacy, University of Copenhagen, Denmark
- Mette Due Theilade Thomsen, External Lecturer, Department of Pharmacy, University of Copenhagen, Denmark
This course is offered as a compulsory part of Master of Medicines Regulatory Affairs.
Priority is given to students enrolled on Master of Medicines Regulatory Affairs. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Atrium is a partner of Master of Medicines Regulatory Affairs. This course is one of 5 courses at the Master's programme, which are offered in collaboration with Atrium.
Atrium is one of Europe’s leading private course providers of practice-based courses in Regulatory Affairs. Their courses are based on collaboration with academia, industry experts and representatives from healthcare authorities.
International educational academy
Atrium is an international educational academy established by The Danish Association of the Pharmaceutical Industry (Lif). As a part of the Danish Association of the Pharmaceutical Industries, Atrium has a close connection to the experts in the Pharmaceutical Industry.
|24-26 September 2024
|Once per year
|Atrium, Greater Copenhagen, Denmark
Master student: 20,273 DKK
Single course participants: 22,273 DKK
The fee includes lunch/coffee.
|Level and credit:
|Master course; 4 ECTS
|See the exam schedule
|6 weeks prior to course start
|To be admitted, you must meet the admission criteria for Master of Medicines Regulatory Affairs