Kursussøgning, efter- og videreuddannelse – Københavns Universitet

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Kursussøgning, efter- og videreuddannelse

Course in Regulatory Affairs in the EU

Practical information
Study year 2016/2017
Time
Autumn
Price

Prices vary according to type of enrolment and nationality. For details please visit: 

EU/EEA citizens

non-EU/EEA citizens

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.

Programme level Part Time Master
ECTS 4 ECTS
Course responsible
  • Lene Jørgensen (14-756e776e3773787b706e777c6e77497c7e776d37747e376d74)
  • Department of Pharmacy
Course number: SMRMIF000U

Course 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.

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.

Recommended prerequisites

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

Remarks

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.

Sign up

Apply here

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.

Studyboard

Study Board for Part-time Master’s Programmes of Pharmaceutical Sciences

Course type

Part time Master and Diploma courses

Teacher

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

Duration

September 7 – 9, 2016

Schedulegroup

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Teaching and learning methods

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.

Language

English

Literature

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.

Workload

Category Hours
Preparation 82
Lectures 21
Theory exercises 5
English 108

Exam (SMRMIF000U)

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

Criteria for exam assessment

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.

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