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Programmes

Pharmaceutical Regulatory Affairs (MPRA)

Master (1 year) of Pharmaceutical Regulatory Affairs (MPRA), 60 ECTS
Health care, social services, and care services

Institution University of Copenhagen (KU)
Campus North Campus
Duration 2 years
Tuition per term (Non-EU/EAA/CH) 6250 EUR
Tuition per term (EU/EAA/CH) 4512 EUR
Website http://mpra.ku.dk/

Description

The aim of the master’s programme is to provide participants with solid theoretical and practical up to date knowledge in international regulatory affairs related to pharmaceutical, biological and biotech product development.

The Master programme:

The master’s programme consists of 8 compulsory courses. Each course is performed in English and is structured around lectures, case studies, group work, workshops and project reports.The introductory course ’Discovery and Development of Medicines’ is an intensive two week module taught at The Faculty of Health and Medical Sciences. The remaining compulsory courses consist of courses from Medicademy in combination with individual project reports undertaken under the guidance of a supervisor from the Faculty. Please find more information in the individual course descriptions below.

In collaboration with a supervisor assigned by the Faculty, the participant identifies relevant elective courses that support the participant's personal study profile. Elective courses must be at postgraduate level (master or PhD-level) and offered by a university in Denmark or abroad.

Master’s project

Career Opportunities  

MPRA graduates are able to:
  • Independently initiate and carry out proper actions between regulatory authorities and the marketing application authorization applicant/holder.
  • Critically examine and evaluate scientific data and conclusions intended for regulatory review
  • Enable application of new methods, tools and strategies to aid successful drug development and regulatory review
  • Enable improvement of the regulatory environment by implementing and upholding good regulatory practices
  • Enable regulatory compliance in pharmacovigilance
  • Train leaders and employees in regulatory aspects of drug development
  • Take independent responsibility for own professional development

About the Degree

he MPRA programme in short
  • Designed for professionals who are employed in regulatory affairs with responsibilities in pharmaceutical/biotech regulatory affairs.
  • An opportunity for participants to establish valuable networks with colleagues and teachers from around the world.
  • Part-time programme equivalent to one year of full-time study (60 ECTS credits) designed to be completed within 3-6 years and for combination with a busy job.

Admission  

Applicants must meet the following criteria:
  • A relevant higher education (minimum bachelor's degree or equivalent)
  • A minimum of 2 years of relevant job experience within regulatory affairs
  • Proficiency in English
Read more about the requirements

Apply through the national electronic admission system, optagelse.dk with all relevant documentation.
Read more about applying via optagelse.dk

To find out whether the level of your foreign certificate or diploma satisfies the general entry requirements, you should contact [your institution] directly. A list of the most commonly recognized exams and diplomas can be found at the Danish Agency for Higher Education http://en.fivu.dk/recognition

Exchange students should contact their home institution for information on application procedures and deadlines.

Tuition

There is a tuition fee for all full-time degree students with a citizenship from outside of EU/EAA/Switzerland. Students within an exchange programme are not required to pay tuition. [If for some reason your insitution deviates from this please write it here]

For Further Information

Information from the Danish Agency for Higher Education can be located at http://en.fivu.dk/

You will find information about the Danish assessment of foreign qualifications in Guide to diploma recognition

About the Educational System in general visit the section The Danish Higher Education System



Spring | All applicants

Application date
Nov 01
Start date
Feb 01

Autumn | All applicants

Application date
May 01
Start date
Sep 01

North Campus

Description

North Campus

With the Copenhagen University Hospital (Rigshospitalet) as the next door neighbour, the Faculty of Science and Faculty of Health and Medical Sciences are very well placed in the North Campus. North Campus is an ideal setting for interdisciplinary reseach fields. Massive investments in research infrastructure, including the construction of the Niels Bohr Building and the Maersk Building,  are currently being made to develop the area around the North Campus into Copenhagen Science City. North Campus is very centrally located and transport links are excellent. Many students and teacher  also use their bike, and biking in Copenhagen is easy and convenient.

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