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Diploma in Regulatory Affairs
A Diploma in Regulatory Affairs will provide you with a profound and updated knowledge of regulatory affairs - from the pharmaceutical legislation in EU to the regulatory environment in the USA and the BRIC countries. You will be introduced to drug development, regulatory strategies, marketing authorisations, the pharmaceutical legislation and law frames, the
different procedures etc, and you can choose to specialize within the veterinary regulatory affairs or medico products.

The diploma programme will give you an overview of the role and responsibilities of a regulatory employee, and you will learn about product life cycle activities and regulatory documentation.

The diploma consists of 8 modules of own choice, choose between:

- 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 3: The Regulatory Affairs Environment in the USA
- Module 4: The Regulatory Affairs Environment in Japan
- 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 10: Biopharmaceuticals – Quality Development and Documentation
- Module 11: Role and Responsibilities of a Regulatory Affairs Professional
- Module 12: Medical Devices - Drug/Device Combinations
- Module 13: The Regulatory Affairs 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

The diploma programme is aimed at pharmacovigilance employees with several years of experience and employees with a relevant Bachelor Degree. Employees with similar qualifications, who wish to further develop their competencies within regulatory affairs, will also benefit from this programme.

To obtain a Diploma in Pharmaceutical Regulatory Affairs, students must pass eight modules of own choice, including the examinations, within 5 years. One module from the Medicademy Pharmacovigilance programme may be included in the Medicademy Regulatory Affairs Diploma.
Regulatory Affairs Network Group
1 January 2012:
Only a limited number of seats available! Application still possible! » Read more
Public Affairs Seminar
1 June 2012:
Sådan påvirkes og samarbejdes med forskellige interessenter af relevans for lægemiddelindustrien » Read more
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
Kritisk artikellæsning, September 2012
13 September 2012:
Læser du ofte videnskabelige artikler? Og har du brug for at kunne gennemskue kvaliteten og fortolke resultaterne af de læste artikler? Så er dette kursus lige noget for dig. » Read more
Personal Workflow
13 November 2012:
Are you pinned down by long and stressful workdays? Have you lost track of all your commitments? Do you want to accomplish more and work less? Then this course is what you need to regain focus and energy. » Read more
Critical Review of Articles, December 2012
6 December 2012:
Do you often have to read and understand scientific articles? Do you find it difficult to evaluate their quality and interpret their results? Then this is the course for you. » Read more
Uddannelsesmuligheder
SEE THE COURSE CALENDAR HERE
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Lif Education, Diploma in Basic Pharmaceutical Medicine, Clinical Research, Drug Development, Medicademy Pharmacovigilance, Medicademy Regulatory Affairs, RA, PV, Pharmacovigilance, Regulatory Affairs
Regulatory Affairs
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Lersø Parkallé 101    DK-2100 Copenhagen    Phone: +45 39 15 09 10    Fax. +45 39 27 60 70    mail@medicademy.net