EU Regulatory Affairs
- Donau-Universität Krems
- Master of Science (M.Sc.)
- 4 semester(s)
- City, country:
- Krems, Lower Austria, Austria
- Introduction to Regulatory Affairs
- Drug Regulatory Affairs I: (Pre-market requirements, types of applications, types of registration procedures, data requirements)
- Drug Regulatory Affairs II: (Medicinal Product post marketing & compliance)
- Medical Device Regulatory Affairs I: (Medical device pre-market requirements, Conformity Assessment and Notified Bodies)
- Medical Device Regulatory Affairs II: (Medical device post marketing & compliance)
- Pharmaco-economics and Decision- Analytics (Benefit of drugs, Cost-Benefit Analysis, Value Dossiers, Market Access, Efficiency and Effectiveness, Admission Strategies)
Pharmamanagement or eRegulatory Affairs)
- Pharma management
- Marketing and Sales in Pharmaceutical/Medical device Industry
- Pharma economics and the political landscape
- Strategic Management und Change Management
- Financial Management
- Software requirements for pharmaceutical/medical
devices quality processes
- Software validation and compliance
- eCTD, RPS and PIM
- Document management
- Change control and life-cycle-management
- Eudravigilance and Clinical trials
- Special Topics in Regulatory Affairs: Generics, Orphan drugs, Cosmetic products, Food supplements, Vet-erinary medicinal products, OTC products, advertising & promotion
- Quality management and compliance: Quality systems, enforcement and national authorities
- Clinical Trail management: Drugs and devices
- Biotech, plasma and blood products: Biotech products, Human tissue regulation, Products from human blood/plasma, biosimilars
- Total fees approx.
- € 7.900,-
- A university degree (at least bachelors) form an Austrian or other equivalent international University, or
- For candidates with no University degree: A/Levels or other high school leaving certificate and at least 4 years work experience in regulatory affairs or a closely related discipline. or
- For candidates with no University degree and no A/Level or other high school leaving certificate: Above 22 years of age, and at least 4 years work experience in regulatory affairs or a closely related discipline plus positive completion of a university admission interview.
|Language(s) of instruction:||English|
|Going abroad:||not possible|
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Danube University Krems is the leading public university for continuing education in Europe. As university for continuing education we specialize in enhancing the qualifications of working professionals. The strength of Danube University Krems is providing university courses that keep pace with the times and are oriented toward current and future societal challenges. Almost 8,000 students are currently enrolled in Danube University Krems, more than 26,500 have already completed their studies successfully. Danube University Krems combines ongoing innovation in research and teaching with the highest standards and holds the seal of quality of the Agency for Quality Assurance and Accreditation Austria (AQ Austria).
Programs of Study
Danube University Krems provides Master’s programs and shorter courses in the following areas:
- Building & Environment
- Health & Medicine
- Arts & Culture
- Media & Communication
- Migration & International Affairs
- Psychotherapy & Social Services
- Law & Administration
- Economics & Business Management
Studying in Krems
The range of studies offered by Danube University Krems is specially designed to meet the requirements of adult students. It gives students the opportunity to complete academic continuing education alongside their careers, thereby acquiring competencies for professional and personal ongoing development. There are specific admission prerequisites, depending on the type of study and the subject area of the course, which you can find out about in the respective course at www.donau-uni.ac.at/study
Campus Krems is equipped with state-of-the-art teaching and research facilities, comfortable accommodations, a varied range of food services, and an arthouse cinema. It offers the ideal environment for learning, research and living.