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  • DGRA
    • Aktuelles
    • Vorstellung
    • Geschäftsstelle
    • Vorstand
    • Mitgliederentwicklung
    • Förderung
        Walter-Cyran-Medaille DGRA-Förderpreis DGRA-Studienpreis Promotionsstipendium
    • Informationsmaterial
    • Satzung
    • Historie
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    • Antrag Mitgliedschaft Firmenmitglied
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    • Schools
    • AGB
  • Degree programme
    • News
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        Master's degree programme Certificate course Single modules Application Student advisory service Examination board
    • In your studies
        Study plan (MDRA-26) Study modules (MDRA-26) Study modules (MDRA-25) Internship Master's thesis Lecturer Literature
    • Testimonials
    • Career perspectives
    • Press and media
    • FAQ
    • Downloads from A-Z
  • Karriere
    • Stellenangebote
    • Praktikumsangebote
  • Kontakt
  • English
    • DGRA
        Business Office Board of Directors Articles of Association
    • Awards and Scholarship
        Walter Cyran Award DGRA Award DGRA Study Award DGRA Doctoral Scholarship
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In your studies 'Drug Regulator Affairs'

©Frank Luerweg / Universität Bonn

Study modules 

MDRA-26 (academic year 2024/2025)

Module 12 Regulatory Management / Decision Making

Authorisation strategy, regulatory aspects and marketing

  • Overview
  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 7
  • 8
  • 9
  • 10
  • 11
  • 12
Teaching time Study time Type of examination Credit points
ca. 15 hours ca. 15 hours Study paper 2
Module leader
Dr. Josef Hofer

Module contents

Decision analysis

  • Methodology
  • Benefit / risk analysis
  • Sensitivity analysis
  • Opportunity-increasing / risk-minimising measures
  • Back up process
  • Decision-making cultures of the world

Development aspects / strategies: company-orientated or product-orientated

  • Development packages and goals
  • Local / international / global
  • Internal / external code development
  • Resource / knowledge management
  • R+D management e.g. project management
  • Cost / time strategies, controlling
  • Marketing specifications

Production aspects / strategies: Active ingredient or finished medicinal product

  • Centralised / decentralised production
  • Centralised / decentralised distribution
  • National / international inspection policy
  • In-house production / contract manufacturing
  • Clinical trial sample production

Medical aspects: clinical trial or market product

  • Medical Need und Pharmaökonomie
  • Medizinkulturen
  • Ethnische Einflußfaktoren auf Indikationsstellung, Dosierungen / Dosisregime etc.
  • Orphan Status

Authorisation aspects/strategies: before, during and after authorisation

  • Selection of the authorisation procedure
  • Development control through regulations (laws, guidelines, recommendations, scientific advice, GMP, GCP, etc.) depending on target regions
  • Quality / content of the dossier
  • Timing of the submission
  • Selection of the reference country (expertise / cooperation)
  • Protection of the documentation
  • Pharmacovigilance

Marketing aspects / strategies

  • Product strategy: medicinal product, food, nutraceutical, medical device
  • Product presentation / product profile
  • Product position (innovation, line extension)
  • Marketing strategy (co-marketing, co-promotion)
  • Product environment (comparative / competitor products)
  • Health policy, pricing, reimbursement
  • Import / export, re-import problems
  • Trademarks
  • Patent situation
  • Life cycle management
  • Post Marketing Surveillance

Study plan

Part 1
Friday 01.08.2025 von 08:30 - 18:30 Uhr Wissenschaftszentrum Bonn
Saturday 02.08.2025 von 08:00 - 16:00 Uhr Wissenschaftszentrum Bonn
Submission of study paper Monday, 08.09.2025  

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Documents

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