Masterstudiengang „Drug Regulatory Affairs"


Modul 04 (WS 2023 / SS 2024)

Generelle Aspekte des Modul 1 (CTD) und Zulassung besonderer Arzneimittelgruppen**

Präsenzzeit Studienarbeiten Prüfungsform Leistungspunkte
ca. 30 Stunden ca. 30 Stunden Studienarbeit 5


  • Dr. Niels Krebsfänger


** Unterrichtssprache Englisch

with emphasis on administrative processes and content of the dossier in module 1
  • E-submission basics: terminology & background
  • Generic and informed consent applications
  • Well established use
  • Content of the dossier (modules 1, 2 and specific aspects for modules 3 and 4)
  • Line extensions
  • The marketing authorization application form
Product Information Management
  • Clinical Trial reports according to Annex one of Directive 2001/83, Clinical Summary and Overview, relevant aspects in the assessment of clinical part of the dossier
  • Assessment process, e.g. efficacy (Wirksamkeitsprüfung)
  • Company Core Data Sheet
  • Summary of Product Characteristics (SmPC)
  • Package leaflet and consultation with target patient groups
  • Labelling (Kennzeichnung)
  • Labelling principles in national phases of EU procedures
Advanced Therapies
  • Relevant Directives, Regulations, Guidelines
  • Definition and classification: advanced therapy medicinal products, tissue products, combined products
  • Authorization procedures
  • Incentives
Biological anti-infectives: Vaccines (active and passive immunization)
  • Definitions and particularities
  • Legal basis for marketing authorisation (authorization procedures) and exemption from the obligation to obtain the marketing authorisation
  • Access to investigational drugs during a public health emergency
  • Specific aspects in the drug development, especially non-clinical and clinical development
  • Influenza vaccines
  • Live vectored vaccines
Blood products
  • Specific regulatory aspects for Blood components
  • Specific requirements for marketing authorization of blood products (example coagulation factors)
  • Plasma Master File
  • Official Batch Release
Specific aspects in marketing applications procedures for herbal and homeopathic medicinal products (Arzneimittel der besonderen Therapierichtungen)
  • Definitions
  • Requirements (AMG, RL 2001/83/EC, pharmacopoeas)
  • Possible MAA/registration procedures and required data on S, Q, E
  • Herbal medicinal products: HMPWP, Botanical nomenclature, Extracts (labeling)
  • Homeopathic medicinal products: the homeopathic principle, manufacturing rules, MAA and registration procedure
  • Anthroposophical products (brief introduction)
Veterinary products
  • Specifics for Veterinary Regulatory Affairs and Definitions
  • Competent Authorities and Veterinary Legislation
  • SmPC: VMP versus HMP
  • Dossier Structure and Content
  • Pharmacovigilance


** Unterrichtssprache Englisch

Teil 1:

Freitag   12. Januar 2024 von 8.30 - 18.30 Uhr
Samstag   13. Januar 2024 von 8.00 - 16.00 Uhr
Ort:    Online-Kurs

Teil 2:

Freitag    19. Januar 2024 von 8.30 - 18.30 Uhr
Samstag   20. Januar 2024 von 8.00 - 16.00 Uhr
  PEI (Paul Ehrlich Institut)
    Abgabe Studienarbeit: 19.02.2024

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