EU Regulatory Affairs
- Donau-Universität Krems
- Master of Science (M.Sc.)
- 4 semester(s)
- City, country:
- 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.
- € 8.900,-
The fees include all 3 modules (CP), or 4 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 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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