EU Regulatory Affairs

Organisation:: Universität für Weiterbildung Krems
Typ:: Part-time
Certificate:: Master of Science (M.Sc.)
Duration:: 4 semester(s)
City, country:: Krems, Lower Austria, Austria

Master Master of Science (M.Sc.), EU Regulatory Affairs - Das Studium

Programme

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
Program Management

Target audience

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.

Emphasis/Curriculum

Compulsory courses (EU Regulatory 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)

Specialization (need to choose 4 from either

Pharmamanagement or eRegulatory Affairs)

Pharmamanagement

Pharma management
Marketing and Sales in Pharmaceutical/Medical device Industry
Pharma economics and the political landscape
Strategic Management und Change Management
Financial Management

eRegulatory Affairs

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

Electives: Need to choose 2

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

Wissenschaftliches Arbeiten

Master-Thesis

Admission/Entrance requirements

Total fees approx.: € 8.900,-

Course Fee:

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

Admission criteria:

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.

Languages

Language(s) of instruction:	English
Going abroad:	not possible

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Organisation

The University for Continuing Education Krems (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 the university 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 the University for Continuing Education Krems, 30,000 have already completed their studies successfully. The university 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
The University for Continuing Education Krems provides Master’s programs and shorter courses in the following areas:

Please find our complete study program in our course catalogue.

Studying in Krems

The range of studies offered by the University for Continuing Education 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.