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 (i.e. what is required of an MAA) in the EU.

WHAT YOU WILL LEARN

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.

COURSE CONTENT

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.

PARTICIPANTS

Participants must meet the following criteria: 
• A relevant bachelor degree or equivalent 
• A minimum of 2 years working experience within regulatory affairs 
• Be proficient in English

COURSE DETAILS

Course dates

3 days, 4-6 September 2019

Course fee

EU/EEA citizens/Master student DKK 18,275

Non EU/EEA citizens/Master student DKK 20,275

EU/EEA citizens/Single course student DKK 20,275

Non EU/EEA citizens/Single course student DKK 22,300

Application deadline

10 July 2019

Applications will be processed by receipt, and applicants are admitted on a "first come, first served" basis. Registration will close when the maximum number of seats are taken. Applicants will be notified of admission within 4 weeks of submitted application. Please note that the course can be cancel or rescheduled if the number of participants fails to meet the required minimum.

EXAMINATION

3 hours written assignment with descriptive questions held on Digital Exam - The online platform for examination at the University of Copenhagen.

Credit

4 ECTS

Examination date

To be announced