24 September 2024

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.

The EU Regulatory Environment - Procedures and Applications

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.

 

 

 

 

 

 

 

 

 

 

 

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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  • 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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Course details

Duration: 3 days 
Dates: 24-26 September 2024
Frequency: Once per year
Place: Atrium, Greater Copenhagen, Denmark
Course fee: EU/EEA citizens
Master student: 20,273 DKK
Single course participants: 22,273 DKK

Non-EU/EEA citizens
Master student: 22,673 DKK
Single course participants: 24,673 DKK

The fee includes lunch/coffee.
Payment conditions

Level and credit: Master course; 4 ECTS
Examination date: See the exam schedule
Application deadline: 6 weeks prior to course start
Admission: To be admitted, you must meet the admission criteria for Master of Medicines Regulatory Affairs


Course dates and application deadlines are announced via the programme newsletter.
Download course curriculum