EU Regulatory Affairs

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. 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.

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. This University course targets regulatory affairs professionals with about 3-5 years experience in regulatory affairs.

Main syllabus - compulsory courses

• Introduction to Regulatory Affairs
• Drug Regulatory Affairs I
• Drug Regulatory Affairs II
• Academic Writing (Master-Thesis)
• Pharmaco-economics and Decision-analytics
• Medical Device Regulatory Affairs I
• Medical Device Regulatory Affairs II

Main syllabus - compulsory courses/Electives (choose two)

• Special Topics in Regulatory Affairs
• Quality Management and Compliance
• Clinical Trial Management
• Biotech, Plasma and Blood products

Specializations: need to choose either Pharma Management or eRegulatory Affairs

Pharma Management

• Pharma Management
• Marketing and Sales in Pharmaceutical/Medical device Industry
• Financial Management
• Strategic Management and Change Management

eRegulatory Affairs

• eCTD, RPS
• Document Management
• Change Control and Life-Cycle-Management
• Software Validation and Compliance

• 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 5 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 5 years work experience in regulatory affairs or a closely related discipline

Important information:

If you do not possess a University degree (at least Bachelor) from an Austrian or other equivalent international University you will have to undergo an interview with our head of center / program manager. This can also be done by telephone. Please note that if you have a degree from an international University which is not legalized yet (see document "Legalization of Foreign Documents" in Higher Education in the drop down "Application form") you will also have to undergo the interview.

Costs:

The course fee amounts € 7.900,-.