Regulatory Affairs in the EU – University of Copenhagen

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Master of Medicines Regulatory Affairs > Courses > Regulatory Affairs in ...

Why should you enroll?

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 plan, and orphan 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.


What do you gain?

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.

Course dates:

  • 4 – 6 September 2017. No vacancy

Exam date:

  •  9 October, 2017

Course fee:

  • DKK 19,975 for EU/EEA citizens
  • DKK 22,560 for non-EU/EEA citizens