SMRMIF000U Course in Regulatory Affairs in the EU
This course is offered in collaboration between University of Copenhagen and Medicademy as part of the Master of Medicines Regulatory Affairs. It is possible to follow the course as a single course student.
This course addresses the current and practical aspects of getting medicines approved in the EU. 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 plans, orphan medicinal products and Risk Management Plans.
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.
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 (MAAs) 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 used during development, application and maintenance of the medical product
Competencies
Make strategic plans for applying for an MA and provide/obtain the needed documentation.
The syllabus comprises selected CHMP/ICH guidelines and EC directives and regulations. 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.
• A relevant bachelor degree or equivalent
• A minimum of 2 years working experience within regulatory affairs
• Proficiency in English
Besides lectures the students must prepare by reading the course literature.
Exam registration is highly recommeded, and to earn the full ECTS credits of the course, you are required to pass the exam.
- Category
- Hours
- Lectures
- 21
- Preparation
- 82
- Theory exercises
- 5
- Total
- 108
- Credit
- 4 ECTS
- Type of assessment
- Course participationParticipation in the course is a requirement for participating in the exam SMRMIF000E - Exam in Regulatory Affairs in the EU
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
Criteria for exam assesment
To achieve the grade passed, the student shall (in an adequate level) be able to:
Knowledge
Explain and discuss the different types of marketing authorization application procedures in the EU
Explain and discuss the needed content for a clinical trial application
Explain and discussways to interact with authorities to obtain 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 opportunities and consequences related to different types of products and submissions e.g. orphan medical products
Understand and apply the EU requirement for paediatric investigation plans and risk management plans
Analyse the overall strategic choices for the regulatory procedure used during development, application and maintenance of the medical product
Competencies
Make strategic plans for applying for an MAA and provide/obtain the needed documentation.
Course information
- Language
- English
- Course code
- SMRMIF000U
- Credit
- 4 ECTS
- Level
- Part Time Master
- Duration
- September 7 – 9, 2016
- Placement
- Autumn
- Schedule
- .
- Continuing and further education
- Price
Prices vary according to type of enrolment and nationality. For details please visit:
Fee includes course materials and meals during the days and a networking dinner the first evening. If textbooks are required, it must be purchased by the participants.
- Study board
- Study Board for Part-time Master’s Programmes of Pharmaceutical Sciences
Contracting department
- Department of Pharmacy
Course responsibles
- Lene Jørgensen (14-746d766d3672777a6f6d767b6d76487b7d766c36737d366c73)
Lecturers
Lene Jørgensen is Head of Studies
Course Responsible:
Eva Maiken Holck - Regulatory Affair Manager, LEO Pharma A/S,
Denmark (chief responsibility)
Mette Due Theilade Thomsen - Principal Scientist, RA Paediatric
Investigation Plan (PIP), RA GLP-1 and Obesity, Novo Nordisk A/S,
Denmark