SMRM18002U The EU Regulatory Environment – Procedures and Applications
This course is offered in collaboration between University of Copenhagen and Atrium as an compulsory part of the Master of Medicines Regulatory Affairs.
See homepage for course dates on the webpage for Master of Medicines Regulatory Affairs
This course is compulsory at 2018-curriculum.
The course is also open for single course student.
This course provides an in-depth overview of and addresses the current strategic and practical aspects of getting medicines approved in the EU. The student will obtain knowledge of the key EU pharmaceutical legislation and key guidelines, the content of a marketing authorisation application (MAA), scientific advice from EMA scientific committees CHMP, paediatrics (PDOC), pharmacovigilance (PRAC) and orphan medicinal products (COMP) - and national authorities, and EU approval procedures as well as post approval activities.
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 market authorisation application (MAA) in the EU.
After completing of the course the student is expected to be able to:
Knowledge
Explain and discuss the EU regulatory framework and the various types of marketing authorisation applications for new medicinal products, generic and similar biological medicinal products, line extensions, variation applications and renewals
Explain and discuss the Centralised Procedure (CP) and the Mutual Recognition Procedure / Decentralised Procedure (MRP/DCP)
Explain and discuss the needed content for a clinical trial application
Explain and discuss the procedures for obtaining scientific advice
Explain and discuss the orphan medicinal product designation
Explain and discuss content and timing of the paediatric investigation plans
Explain and discuss the content of risk management plans
Skills
Analyse and consider the requirements for a MAA
Identify, analyse and consider regulatory opportunities and consequences related to different types of products and submissions e.g. orphan medical products
Comply with the EU requirement for paediatric investigation plans and risk management plans
Analyse the overall strategic choices for the regulatory procedure during life cycle management, development, application and maintenace of the medical product
Prepare written meeting requests, draft questions, assemble background package, and documents for and be the interface in the interaction with EMA
Competencies
Participate and lead international teams in understanding and meeting EU regulators requirements for the study and registration of new products in the EU
Develop strategic plans for applying for an MA and provide/obtain the needed documentation.
Evaluate and propose strategic scenarious on different regulatory pathways for various EU situations
Adivise teams on the impact of current and draft legislation and guidelines for the EMA, the european commission and international (ICH) guidelines on medicines
The syllabus comprises selected guidelines and legislation from EU and ICH. A list of reading material will be distributed electronically approx. 4 weeks before the course. The course participants are expected to read or familiarize themselves with the syllabus, corresponding to approximately 1200 pages.
Besides lectures the students must prepare by reading the course literature.
- Category
- Hours
- Lectures
- 21
- Preparation
- 61
- Theory exercises
- 5
- Exam Preparation
- 20
- Exam
- 3
- Total
- 110
Application deadline is 6 weeks before the first day of instruction. If we have empty seats after the application deadline, it is possible to apply after deadline.
- Credit
- 4 ECTS
- Type of assessment
- Written assignment, 3 hours
- Type of assessment details
- 3 hours written assignment with descriptive questions held on Digital Exam - The online platform for examination at the University of Copenhagen.
- Aid
- All aids allowed
The use AI chatbots, such as ChatGPT or any similar softwares, is not allowed during exams.
- Marking scale
- 7-point grading scale
- Censorship form
- No external censorship
- Exam period
Announced in the MRA exam schedule on mra.ku.dk
- Re-exam
The exam form for the reexam is the same as the ordinary exam. See dates in the exam schedule on mra.ku.dk
Criteria for exam assesment
To achieve the grade passed, the student shall (in an adequate level) be able to:
Knowledge
Explain and discuss the EU regulatory framework and the various types of marketing authorisation applications for new medicinal products, generic and similar biological medicinal products, line extensions, variation applications and renewals
Explain and discuss the Centralised Procedure (CP) and the Mutual Recognition Procedure / Decentralised Procedure (MRP/DCP)
Explain and discuss the needed content for a clinical trial application
Explain and discuss the procedures for obtaining scientific advice
Explain and discuss the orphan medicinal product designation
Explain and discuss content and timing of the paediatric investigation plans
Explain and discuss the content of risk management plans
Skills
Analyse and consider the requirements for a MAA
Identify, analyse and consider regulatory opportunities and consequences related to different types of products and submissions e.g. orphan medical products
Comply with the EU requirement for paediatric investigation plans and risk management plans
Analyse the overall strategic choices for the regulatory procedure during life cycle management, development, application and maintenace of the medical product
Competencies
Develop strategic plans for applying for an MA and provide/obtain the needed documentation.
Evaluate and propose strategic scenarious on different regulatory pathways for various EU situations
Course information
- Language
- English
- Course code
- SMRM18002U
- Credit
- 4 ECTS
- Level
- Part Time Master
- Duration
- 3 days
- Placement
- Spring And Autumn
- Schedule
- 3 days full time
- Course capacity
- 30
Study board
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Pharmacy
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinators
- Eva Maiken Holck (eva.maiken.holck@sund.ku.dk)
- Mette Due Theilade Thomsen (mette.thomsen@sund.ku.dk)
Eva Maiken Holck - Regulatory Affairs CMC senior specialist, Nykode Therapeutics, Denmark (chief responsible)
Mette Due Theilade Thomsen - CEO, PIP Adviser, PIP Advisor