EU Regulatory Affairs

Certified Program
Master of Science in EU Regulatory Affairs

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

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.

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