The EU Regulatory Environment – Procedures and Applications

Course content

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.

Education

This course is offered in collaboration between University of Copenhagen and Atrium as an compulsory part of the Master of Medicines Regulatory Affairs.

 

See course calender for course dates

 

This course is compulsory at 2018-curriculum.

The course is also open for single course student.

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 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 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.

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.

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

Collective
Continuous feedback during the course of the semester
ECTS
4 ECTS
Type of assessment
Written assignment, 3 hours
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
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assessment

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

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 61
  • Lectures
  • 21
  • Theory exercises
  • 5
  • Exam
  • 3
  • Exam Preparation
  • 20
  • English
  • 110