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
deepen in subjects Pharmamanagement
or in subjects eRegulatory Affairs
and choose 2 of the options
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