SMRMIF000U  Course in Regulatory Affairs in the EU

Volume 2017/2018
Education

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.

Content

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.

This course is connected to the exam SMRMIF000E Exam in Regulatory Affairs in the EU. To earn the full 5 ECTS credit you are required to pass the exam.

Learning Outcome

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.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years working experience within regulatory affairs
• Proficiency in English
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. Following the group works, the groups will present their works to the plenum and thereby ensure input and feedback from the study participants as well as from the instructors.
Besides lectures the students must prepare by reading the course literature.
This course is connected to the exam: SMRMIF000E Exam in Regulatory Affairs in the EU .
Exam registration is highly recommeded, and to earn the full ECTS credits of the course, you are required to pass the exam.
Credit
4 ECTS
Type of assessment
Course participation
Participation 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
Exam period

Announced in the MRA exam schedule on http://mra.ku.dk/calender/exams/

Re-exam

Announced in the MRA exam schedule on http://mra.ku.dk/calender/exams/

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.

  • Category
  • Hours
  • Preparation
  • 82
  • Lectures
  • 21
  • Theory exercises
  • 5
  • Total
  • 108