• Graduation

    Certificate

  • ECTS-Points

    39

  • Learning format

    Distance learning

  • Duration

    2 semesters, part time

  • Start

    Winter semester 2024/25

  • Costs

    EUR 4.900,--

  • Language

    English

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.

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
Attention

Increase in costs from May 2, 2024 to EUR 5.900,-

 

Any questions?

We’re here to help.

Or contact us directly.

Subjects

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)

Subjects

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:

Module 1: November 8th – 10th 2024

Module 2: March 14th - 16th 2025

Module 3: June 13th - 15th 2025

Teaching times: 9:00 AM to 6:00 PM (CET / CEST)

Location: Online via Zoom (no on campus classroom teaching)


All dates and locations are subject to change.

Here you can find more information about the Certificate Program.

 

Admission requirements

Student in the library

Scholarships and funding

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.

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