Master of Pharmaceutical Regulatory Affairs

www.farma.ku.dk/mpra

Master of Pharmaceutical Regulatory Affairs is offered by the Faculty of Pharmaceutical Sciences at the University of Copenhagen, and has been developed together with the Danish Medicines Agency and Medicademy. The programme is aimed at regulatory employees with several years of experience and employees with a relevant Bachelor Degree. The programme takes 2-6 years.

The principle language of instruction is English, and the programme consists of mandatory courses, elective courses and a Master project, and will provide you with a profound knowledge of national and international regulatory affairs. You will also have the opportunity to create a new and invaluable network with colleagues and lecturers from all over the world, and benefit from it throughout your career.

The Master programme is structured as follows:

- Discovery and Development of Medicines (introductory course at the University of Copenhagen)

- 8 mandatory Medicademy modules:
(Module 1: The Pharmaceutical Law Frames in the EU)
(Module 2: EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials
and Orphan Drug Designation)
(Module 5: Regulatory Strategic Considerations during Global Drug Development)
(Module 6: Quality - Drug Substance and Drug Product)
(Module 7: Non-Clinical Development and Documentation)
(Module 8: Clinical Development and Documentation)
(Module 9: Product Life Cycle Activities)
(Module 11: Role and Responsibilities of a Regulatory Affairs Professional)

- Elective courses, choose between the following Medicademy modules:
(Module 3: The Regulatory Affairs Environment in the USA)
(Module 4: The Regulatory Affairs Environment in Japan)
(Module 10: Biopharmaceuticals - Quality Development and Documentation)
(Module 12: Medical Devices - Drug/Device Combinations)
(Module 13: The Regulatory Environment in Major Markets outside ICH - Optimizing your Regulatory Strategy in the BRIC Countries (Brazil, Russia, India and China)
(Module 14: Veterinary Regulatory Affairs in the EU)
(Module 15: The Regulatory Environment for Generic Products in the EU)

- Master project

The introductory course at the University of Copenhagen takes place each year in January, and the Medicademy modules are held on an ongoing basis.

Contact
The programme has no registration deadline, and you can apply anytime on the following website: www.farma.ku.dk/MPRA.

If you have any questions regarding entry requirements or practical information, please contact the Master's Administration at the University of Copenhagen: Email: master@farma.ku.dk or visit the MPRA website: www.farma.ku.dk/MPRA

Master’s Administration
The Faculty of Pharmaceutical Sciences
Universitetsparken 2
DK-2100 Copenhagen, Denmark
Tel: +45 35 30 65 58. Fax: +45 35 30 60 01

Regulatory Affairs Network Group

1 January 2012:

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Medicademy Module R9: Product Life Cycle Activities

29 May 2012:

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Exam: Medicademy Module R8: Clinical Development and Documentation

1 June 2012:

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Exam: Medicademy Module R1: The Pharmaceutical Law Frames in the EU

12 June 2012:

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Exam: Medicademy Module R9: Product Life Cycle Activities

3 September 2012:

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Medicademy Module R2: EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials and Orphan Drug Designation

5 September 2012:

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Introduktion til lægemiddelregistrering

13 September 2012:

Vil du gerne vide mere om lægemiddelregistrering og -lovgivning i EU? Dette kursus hjælper dig til at forstå registreringsansøgninger og procedurer, vedligeholdelse af godkendte lægemidler og en registreringsafdelings mange opgaver. » Read more

Hot Topic Seminar - Latest News within the Pharmacovigilance Legislation

21 September 2012:

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Medicademy Module R11: Roles and Responsibilities of a Regulatory Affairs Professional

27 September 2012:

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Exam: Medicademy Module R2: EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials and Orphan Drug Designation

8 October 2012:

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Medicademy Module R12: Medical Devices - Drug/Device Combinations

9 October 2012:

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