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Graduation
Certificate
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ECTS-Points
39
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Learning format
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Duration
2 semesters, part time
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Start
Winter semester 2025/26
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Costs
EUR 5.900,--
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Language
English
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Curriculum
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.
Mag.(FH)
Ariana Walzer
Administrative assistant
Or contact us directly.
Curriculum
EU Regulatory Affairs, CP
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Contents
(Pre-market requirements, types of applications, types of registration
procedures, data requirements) -
Contents
(Medicinal Product post marketing & compliance)
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Contents
(Medical device pre-market requirements, Conformity Assessment
and Notified Bodies) -
Contents
(Medical device post marketing & compliance)
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Contents
(Benefit of drugs, Cost-Benefit Analysis, Value Dossiers, Market
Access, Efficiency and Effectiveness, Admission Strategies)
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Contents
Generics, Orphan drugs, Cosmetic products, Food supplements,
Veterinary medicinal products, OTC products, advertising &
promotion -
Contents
Quality systems, enforcement and national authorities
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Contents
Drugs and devices
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Contents
Biotech products, Human tissue regulation, Products from human
blood/plasma, biosimilars
Study Program Director
Downloads and Dates
Here you can find more information about the Certificate Program.
Admission
Admission requirements
Application process
- Contact us to clarify your expectations of the program and to check the admission requirements
- Online application (enter the study code UM 992 642 in the online tool).
- Carrying out the selection procedure (interview with the head of degree program)
- 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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