Masterstudiengang „Drug Regulatory Affairs"


Modul 04 (WS 2018 / SS 2019)

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


Regulatory Intelligence

Abridged / Generic Applications with emphasis on administrative processes and content of the dossier in module 1 
•    Essentially similarGeneric and informed consent applications
•    Bibliographical applicationsWell established use
•    Content of the dossier (modules 1, 2 and specific aspects for modules 3 and 4)
•    Line-extensions
•    Scientific Advice at the BfArM
•    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

•    Definitions and specific aspects
•    Combinations
•    Influenza vaccines
•    Authorization procedure (brief introduction)

Blood products
•    Specific regulatory aspects for Blood components
•    Official Batch Release
•    Specific requirements for marketing authorization of blood products (example coagulation factors)
•    Plasma Master File

Specific aspects in marketing applications procedures for herbal and homeopathic medicinal products (Arzneimittel der besonderen Therapierichtungen)
•    Definitions
•    Requirements (AMG, AMPrüfRL, 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 according to PhEur
•    Registration procedure
•    Anthroposophical products (brief introduction)

Veterinary products
•    Specifics for Veterinary Regulatory Affairs and DefinitionsDefinitions, Veterinary Legislation in Germany, EU and globally
•    Competent Authorities and Veterinary LegislationEMEA, CVMP, HMA and CMD(v), VICH, Animal Health Industry Associations
•    SmPC: VMP versus HMPSpecific aspects of the SmPC
•    Dossier Structure and ContentParts of a Dossier - Part I, II, IIIA Safety, IIIB Residues, IV
•    Withdrawal PeriodsPharmacovigilance
•    New EU Regulation on Veterinary Medicinal ProductsEcotoxicity


Teil 1:    
Freitag   18. Januar 2019 von 8.30 - 18.30 Uhr
Samstag   19. Januar 2019 von 8.00 - 16.00 Uhr
Ort:    Uni-Club
Teil 2:    
Freitag    25. Januar 2019 von 8.30 - 18.30 Uhr
Samstag   26. Januar 2019 von 8.00 - 16.00 Uhr
  Paul-Ehrlich-Institut (PEI), Langen
    Abgabe Studienarbeit: 25.02.2019

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