EU Regulatory Affairs

Certified Program
Master of Science in EU Regulatory Affairs

Contents

Examination subjects

EU Regulatory Affairs, CP

Introduction to Regulatory Affairs

Lernformat

Blended Learning

ECTS-Punkte

4

Drug Regulatory Affairs I

Inhalte

(Pre-market requirements, types of applications, types of registration
procedures, data requirements)

Lernformat

Blended Learning

ECTS-Punkte

5

Drug Regulatory Affairs II

Inhalte

(Medicinal Product post marketing & compliance)

Lernformat

Blended Learning

ECTS-Punkte

5

Medical Device Regulatory Affairs I

Inhalte

(Medical device pre-market requirements, Conformity Assessment
and Notified Bodies)

Lernformat

Blended Learning

ECTS-Punkte

5

Medical Device Regulatory Affairs II

Inhalte

(Medical device post marketing & compliance)

Lernformat

Blended Learning

ECTS-Punkte

5

Pharmaco-economics and Decision- Analytics

Inhalte

(Benefit of drugs, Cost-Benefit Analysis, Value Dossiers, Market
Access, Efficiency and Effectiveness, Admission Strategies)

Lernformat

Fernstudium

ECTS-Punkte

5

choose two of the options

Special Topics in Regulatory Affairs

Inhalte

Generics, Orphan drugs, Cosmetic products, Food supplements,
Veterinary medicinal products, OTC products, advertising &
promotion

Lernformat

Blended Learning

ECTS-Punkte

5

Quality management and compliance

Inhalte

Quality systems, enforcement and national authorities

Lernformat

Blended Learning

ECTS-Punkte

5

Clinical Trial management

Inhalte

Drugs and devices

Lernformat

Blended Learning

ECTS-Punkte

5

Biotech, plasma and blood products

Inhalte

Biotech products, Human tissue regulation, Products from human
blood/plasma, biosimilars

Lernformat

Blended Learning

ECTS-Punkte

5

Examination subjects

Introduction to Regulatory Affairs

Lernformat

Blended Learning

ECTS-Punkte

4

Drug Regulatory Affairs I

Inhalte

(Pre-market requirements, types of applications, types of registration
procedures, data requirements)

Lernformat

Blended Learning

ECTS-Punkte

5

Drug Regulatory Affairs II

Inhalte

(Medicinal Product post marketing & compliance)

Lernformat

Blended Learning

ECTS-Punkte

5

Medical Device Regulatory Affairs I

Inhalte

(Medical device pre-market requirements, Conformity Assessment
and Notified Bodies)

Lernformat

Blended Learning

ECTS-Punkte

5

Medical Device Regulatory Affairs II

Inhalte

(Medical device post marketing & compliance)

Lernformat

Blended Learning

ECTS-Punkte

5

Pharmaco-economics and Decision- Analytics

Inhalte

(Benefit of drugs, Cost-Benefit Analysis, Value Dossiers, Market
Access, Efficiency and Effectiveness, Admission Strategies)

Lernformat

Fernstudium

ECTS-Punkte

5

Dates

EU Regulatory Affairs SCHEDULE:
Modul 1
22nd of Nov. 2019 Course opening (Begin 8:30)
23rd of Nov. 2019
24th of Nov. 2019

Modul 2
05th of March 2020
06th of March 2020
07th of March 2020
08th of March 2020

Modul 3
19th of June 2020
20th of June 2020
21st of June 2020
END CERTIFIED PROGRAM

Modul 4 Specialization Pharma Management or eRegulatory Affairs
dates in progress

 

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