Contents
Examination subjects
EU Regulatory Affairs, CP
You have to choose only two of the specialization modules.
Introduction to Regulatory Affairs
ECTS-Points
4
Drug Regulatory Affairs I
Contents
(Pre-market requirements, types of applications, types of registration
procedures, data requirements)
ECTS-Points
5
Drug Regulatory Affairs II
Contents
(Medicinal Product post marketing & compliance)
ECTS-Points
5
Medical Device Regulatory Affairs I
Contents
(Medical device pre-market requirements, Conformity Assessment
and Notified Bodies)
ECTS-Points
5
Medical Device Regulatory Affairs II
Contents
(Medical device post marketing & compliance)
ECTS-Points
5
Pharmaco-economics and Decision- Analytics
Contents
(Benefit of drugs, Cost-Benefit Analysis, Value Dossiers, Market
Access, Efficiency and Effectiveness, Admission Strategies)
ECTS-Points
5
choose two of the options
Special Topics in Regulatory Affairs
Contents
Generics, Orphan drugs, Cosmetic products, Food supplements,
Veterinary medicinal products, OTC products, advertising &
promotion
ECTS-Points
5
Quality management and compliance
Contents
Quality systems, enforcement and national authorities
ECTS-Points
5
Clinical Trial management
Contents
Drugs and devices
ECTS-Points
5
Biotech, plasma and blood products
Contents
Biotech products, Human tissue regulation, Products from human
blood/plasma, biosimilars
ECTS-Points
5
Examination subjects
Introduction to Regulatory Affairs
ECTS-Points
4
Drug Regulatory Affairs I
Contents
(Pre-market requirements, types of applications, types of registration
procedures, data requirements)
ECTS-Points
5
Drug Regulatory Affairs II
Contents
(Medicinal Product post marketing & compliance)
ECTS-Points
5
Medical Device Regulatory Affairs I
Contents
(Medical device pre-market requirements, Conformity Assessment
and Notified Bodies)
ECTS-Points
5
Medical Device Regulatory Affairs II
Contents
(Medical device post marketing & compliance)
ECTS-Points
5
Pharmaco-economics and Decision- Analytics
Contents
(Benefit of drugs, Cost-Benefit Analysis, Value Dossiers, Market
Access, Efficiency and Effectiveness, Admission Strategies)
ECTS-Points
5
deepen in subjects Pharmamanagement
or in subjects eRegulatory Affairs
and choose 2 of the options
Dates
Next course: winter term 2022
Module 1:
November 18th – 20th 2022
Module 2:
March 16th – 19th 2023
Module 3:
June 16th – 18th 2023
End Certified Program
Specialization modules for MSc (choose one)
Module 4 Specialization "Pharma Management":
November 9th - 12th 2023
Module 4 Specialization "eRegulatory Affairs":
Summer semester 2024 / Dates to be confirmed
Locations: Vienna and Danube University Krems
The lectures take place from 9:00 AM to 6:00 PM.
All dates and locations are subject to change.