MASTER OF PHARMACEUTICAL REGULATORY AFFAIRS – MPRA
WWW.FARMA.KU.DK/MPRA

The Faculty of Pharmaceutical Sciences at the University of Copenhagen offers a master’s degree in collaboration with Medicademy and the Danish Medicines Agency: Master of Pharmaceutical Regulatory Affairs (MPRA). The Faculty’s study board for part-time master’s programmes governs the programme.

MPRA is designed for professionals in regulatory affairs who have a relevant bachelor’s degree and at least two years of experience in pharmaceutical/biotech regula¬tory affairs. MPRA is a 2-6 year part-time programme, equivalent to one year of full-time study. In addition to earning a master’s degree, participants have the oppor-tunity to develop a network of international colleagues that can be invaluable as future career and knowledge resources.

ADMISSION REQUIREMENTS
Applicants to the MPRA programme must meet the following criteria:
• Hold a relevant bachelor’s degree, professional bach-elor’s degree, diploma degree or equivalent.      
  Relevant disciplines are chemistry, biochemistry, pharmacy, medicines, biomedicines, human biology,   
  molecular biology, veterinary sciences, health sciences, nursing and engineering.
• Have at least two years of relevant work experience related to drug registration
• Be proficient in English 
 
STRUCTURE OF THE MPRA PROGRAMME
The MPRA programme consists of three parts:
• Compulsory (40 ECTS credits)
• Elective (0-8 ECTS credits)
• Master’s project (12-20 ECTS credits)

For further information about the ECTS credit system, please visit the MPRA website at: www.farma.ku.dk/MPRA

Compulsory Courses
The compulsory survey course (5 ECTS credits) Discovery and Development of Medicines is an intensive two-week master’s course held at the Faculty. The other compul¬sory courses are Medicademy modules combined with individual project reports under the auspices of the Fa¬culty. Project reports are graded according to the Danish 7-point grading scale which is compatible with the ECTS grading scale.

Elective Courses
Participants have a certain amount of leeway in selecting electives, as long as the courses are relevant to regula¬tory affairs within the pharmaceutical or biotechnological industry. In collaboration with a supervisor assigned by The Faculty of Pharmaceutical Sciences, participants identify relevant elective courses to support their personal study profile. Elective courses must be at postgraduate level (master’s or PhD level) and offered by a university in Denmark or abroad. The elective part of the programme can also be used for an expanded master’s project.

Pre-approved elective courses are:
• The Regulatory Affairs Environment in the USA (Medicademy course + project report)
• The Regulatory Affairs Environment in Japan (Medicademy course + project report)
• Biopharmaceuticals – Quality Development and Documentation (Medicademy course + project report)
• Medical Devices – Drug/Device Combinations (Medicademy course + project report)
• QA, QC, GXP for Pharmaceutical Production (offered by the Faculty)

The master’s project completes the MPRA programme. It is a practice-oriented research project that allows participants to apply their acquired skills and knowledge to the host organization or company. The project is supervised by a university lecturer and often also by a supervisor from the participant’s host organization or company.

The MPRA must be completed within a timeframe of six years.

COMPULSORY COURSES

CREDIT TRANSFER
The study board can approve elements of master’s programmes successfully completed at other Danish or international universities. Course credit may be given for Medicademy modules already passed.

TUITION
Entry fee
To enter the full master’s programme, participants pay a fee of DKK 15,000 (approx. EUR 2,000) at the time of registration. The fee covers library facilities, administration, study guidance and guarantees that the student can complete the master’s programme in two years.

Compulsory Courses
Fees covering Medicademy courses are collected directly by Medicademy. The Faculty of Pharmaceutical Sciences collects the fee for the introductory course Discovery and Development of Medicines as well as all fees related to project reports.

Master’s Project
Participants are required to pay a fee of DKK 30,000 (approx. EUR 4,000) before beginning supervision for their master’s project.

BEHIND MPRA
The MPRA faculty comprises leading professors, industrialists, researchers, and managers from Denmark and abroad.

A study board comprising internal and external teachers and active students governs the MPRA programme.

The MPRA steering committee is composed of representatives from relevant companies, organizations and authorities from the pharmaceutical sector.

APPLICATION FOR THE FULL MPRA PROGRAMME
There is no application deadline for the full MPRA programme, but if you want to start with the introductory survey course Discovery and Development of Medicines which is expected to be held every year in January, you must apply before 1 November. The application form is available at the MPRA website: www.farma.ku.dk/MPRA

CONTACT
For further information please contact the Master’s Administration:
Email: master@farma.ku.dk