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: winter term 2021

Module 1:

November 19th – 21st 2021

Module 2:

March 10th – 13th 2022

Module 3:

June 10th – 12th 2022

End Certified Program

Specialization modules for MSc (choose one)

Module 4 Specialization Pharma Management:

Winter semester 2022 / Dates to be confirmed

Module 4 Specialization eRegulatory Affairs:

Summer semester 2023 / Dates to be confirmed

Locations: Vienna and Danube University Krems

All dates and locations are subject to change.

 

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