• Graduation

    Certificate

  • ECTS-Points

    39

  • Learning format

    Distance learning

  • Duration

    2 semesters, part time

  • Start

    Winter semester 2024/25

  • Costs

    EUR 5.900,--

  • Language

    English

  • Curriculum

    Curriculum (PDF | 86 KB)

Apply now
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.
Salma Michor

The program is ideal for regulatory professionals looking to advance their career in the field covering EU pharmaceutical and medical devic registration and includes related areas like food supplements, cosmetics and veterinary products.

Salma Michor
PhD, RAC

Managing Director and Global Unit Head Regulatory Affairs | QBD GROUP AUSTRIA

 

Any questions?

We’re here to help.

Ariana Walzer

Mag.(FH)
Ariana Walzer

Administrative assistant

Or contact us directly.

To contact form
ECTS
EU Regulatory Affairs, CP

  • Contents

    (Pre-market requirements, types of applications, types of registration
    procedures, data requirements)

  • Contents

    (Medicinal Product post marketing & compliance)

  • Contents

    (Medical device pre-market requirements, Conformity Assessment
    and Notified Bodies)

  • Contents

    (Medical device post marketing & compliance)

  • Contents

    (Benefit of drugs, Cost-Benefit Analysis, Value Dossiers, Market
    Access, Efficiency and Effectiveness, Admission Strategies)

ECTS

  • Contents

    Generics, Orphan drugs, Cosmetic products, Food supplements,
    Veterinary medicinal products, OTC products, advertising &
    promotion

  • Contents

    Quality systems, enforcement and national authorities

  • Contents

    Drugs and devices

  • Contents

    Biotech products, Human tissue regulation, Products from human
    blood/plasma, biosimilars

The lectures take place as online presence via Zoom on the following dates:

Michael Ogertschnig

Mag.
Michael Ogertschnig, MBA

Study Program Manager - Department for Economy and Health

Doris Behrens

Univ.-Prof. Dipl.-Ing. Dr.
Doris Behrens

Deputy Dean - Faculty of Health and Medicine | Head of Department for Economy and Health - Faculty of Health and Medicine

Here you can find more information about the Certificate Program.

 

Folder
PDF | 310 KB
Supplementary sheet Curriculum
PDF | 100 KB
Dates Winter semester 2024
PDF | 214 KB
Appendix-Continuing-Education-Tuition-Fee
PDF | 149 KB

Admission requirements

see Information sheet

Student in the library

Scholarships and funding

Show financing options

Application process

  1. Contact us to clarify your expectations of the program and to check the admission requirements
  2. Online application (enter the study code UM 992 642 in the online tool).
  3. Carrying out the selection procedure (interview with the head of degree program)
  4. Admission to the degree program

When applying online, you will be asked for the specific semester (winter semester 2024) and the Study Code. We look forward to receiving your application and to welcoming you soon at the University for Continuing Education Krems.

Apply now | Study Code UM 992 642

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