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        Master's degree programme Certificate course Single modules Application Student advisory service Examination board
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        Study plan (MDRA-26) Study modules (MDRA-26) Study modules (MDRA-25) Internship Master's thesis Lecturer Literature
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In your studies 'Drug Regulator Affairs'

©Frank Luerweg / Universität Bonn

Study modules 

MDRA-26 (academic year 2024/2025)

Module 4 General Aspects of Module 1 (CTD), Registration of Special Medicinal Products

Formal requirements for authorisation and contents of Module 1 CTD, product information texts (summary of product characteristics, package leaflet), special requirements for special therapeutic indications, veterinary medicinal products, blood products, vaccines and advanced therapy medicinal products (ATMPs)

  • Overview
  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 7
  • 8
  • 9
  • 10
  • 11
  • 12
Teaching time Study time Type of examination Credit points
ca. 30 hours ca. 30 hours Study paper 5
Module leader
Dr. Niels Krebsfänger

Module contents

MA-Applications
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


Study plan

Part 1
Friday 17.01.2025 von 08:30 - 18:30 Uhr Universitätsclub Bonn e.V.
Saturday 18.01.2025 von 08:00 - 16:00 Uhr Universitätsclub Bonn e.V.
Part 2
Friday 24.01.2025 von 08:30 - 18:30 Uhr Online
Saturday 25.01.2025 von 08:00 - 16:00 Uhr Online
Submission of study paper Monday, 24.02.2025  

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