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 EU Regulatory Affairs
Module 1 (Due to Covid-19 no classroom teaching. Change to online settings):
November 20th – 22nd 2020
Module 2:
March 18th – 21st 2021 (to be confirmed)
Module 3:
June 11th – 13th 2021 (to be confirmed)
End Certified Program
Specialization modules for MSc (choose one)
Module 4 Specialization Pharma Management:
To be confirmed
Module 4 Specialization eRegulatory Affairs:
To be confirmed
Locations: Vienna and Danube University Krems
Dates and locations are subject to change.