EU Regulatory Affairs
- Donau-Universität Krems
- Master M.Sc.
- 4 semester(s)
- Krems, Lower Austria, Austria
The pharmaceutical and medical device sectors are one of the most highly regulated in the world second only to the nuclear and aerospace industries. In order to keep abreast of current trends it is necessary for professionals working in those industries to be well acquainted with current and future trends and regulations. Regulatory Affairs is an emerging profession increasingly gaining in importance.
Participants will receive a thorough in depth training in all aspects of EU regulatory affairs covering both the pharmaceutical and medical device sectors. Due to the growing importance of regulatory affairs and the real deficit of higher education courses on this topic in the EU, this course is expected to fill an important gap in the pharmaceutical/medical device sector in Europe.
Mag. Michael Ogertschnig
This University course targets regulatory affairs professionals with about 3-5 years experience in regulatory affairs. The course will be of special interest for regulatory affairs professionals from these sectors attracting students from all over EU.
Due to current development in eCommerce and ICT this course will offer the possibility of specialization in eRegulatory Affairs. In addition a specialization in pharma management will be offered to prepare students for strategic management positions within regulatory affairs.
Compulsory courses (EU Regulatory Affairs)
Pharmamanagement or eRegulatory Affairs)
- 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.
- € 7.150,-
The fees include all 8 modules (CP), or 12 modules (MSc), the EU fundamentals book, plus any lecturing materials used. The fees do not include other resources for the RAC such as a self assessment exam or the RAC registration fees. These need to be purchased separately from raps.
In general, the whole tuition is to be paid before the start of the first semester. In exceptional cases paying in 2 installments or on a modular basis is possible. Included in the tuition are exam fees and lecturing materials. If you have to repeat an examination you will be charged an administrative fee of € 50,-. For the RAC the fees listed on the raps website apply
- 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 has specialized in postgraduate academic studies and offers exclusive courses in the fields of economics and management, communications, IT and media, medicine and health, law, European integration and public administration, education and cultural sciences as well as of building and ecology. Being a European model project, Danube University Krems combines high quality in education, research and consulting with excellent customer orientation and service. More than 3,500 students from 50 countries are enrolled in over 150 academic courses.
The majority of the students of Danube University Krems have a university degree. Therefore, the main part of university teaching in Danube University Krems consists of courses which are concluded with an internationally recognized Master’s degree such as Master of Business Administration (MBA), Master of Science (MSc), Master of Arts (MA) or Master of Laws (LL.M.). The range of courses offered here extends from executive MBA, IT consulting, European Union law, solar architecture and music management to health care management, psychotherapy and special fields of dentistry. Danube University Krems also offers a number of short courses and seminars.
Danube University Krems is located in one of Europe’s most beautiful cultural landscapes, the Wachau region along the Danube, which has been named a world cultural heritage site by the UNESCO. A renovated tobacco factory dating back to the onset of the 20th century and new buildings on Campus Krems provide students and educators with an open, innovative, and motivational atmosphere for research and studying. The new campus, which was opened in 2005, provides the region with a new landmark of international acclaim.
Studying in Krems
Krems is a traditional educational town - with 30 schools and high schools attended by more than 10,000 students. Therefore, Krems’ environment is richly furnished with restaurants, hotels, guest-houses and students’ hostels, as well as leisure-time and cultural facilities. The idyllic environment of the Wachau, its exquisite wines and numerous sports facilities contribute in significant measure to the quality of life of students at the Danube University Krems.
Historic buildings and architecture from the middle-ages in the parts of Krems and Stein show for a meaningful past. The community, already mentioned in 995 as "urbs chremisa", was once the center of salt and wine trading and is one of the oldest towns in the country.
Strolling through the medieval alleyways, tasting wine in closed-down monasteries, relaxing in a café by the street, and amusedly smiling in the museum of caricatures: art and culture can be experienced and lived in Krems. The folk music festival "Glatt & Verkehrt" (Smooth & Traffic), the Lower Austrian Danube Festival, the film program of the Austrian Film Gallery, and the exhibitions at the internationally renowned Art Center Krems are the highlights of the town’s annual event calendar. As a member of the art-mile in Krems, the Danube University of Krems is a regular part of the local art and culture scene.
The Danube University of Krems is an ideal starting point for jogging, cycling, playing squash and tennis, or simply for taking a walk through the vineyards. Oarsmen and swimmers can pursuit their hobbies in the nearby Danube River.
- Mag. (FH) Ariana Walzer
- +43 (0)2732 893 2820