Master's Course "Drug Regulatory Affairs"

Study Modules

Modul 12 (WS 2017 / SS 2018)

Decision analytics

attendance approx. Seminar Paper Method of examination Credit
approx. 15 h approx. 15 h seminar paper 2

Module Supervisor

  • Dr. Josef Hofer, Grafing

Topics

Decision analytics
  • Methodology
  • Risk-benefit analysis
  • Sensitivity consideration
  • Opportunity-enhancing / risk-minimizing measures
  • Backup process
  • Decision-making cultures of the world
Development aspects / strategies: company and product-oriented
  • Development packages and goals
  • Local / international / global
  • Internal / external co-development
  • Resource / knowledge management
  • R&D management, e.g. project management
  • Costs / time strategies, controlling
  • Marketing requirements
Development aspects / strategies: active substance and finished pharmaceutical product
  • Centralized / decentralized production
  • Centralized / decentralized distribution
  • National / international inspection policies
  • Own production / licensed production
  • Clinical sample production
Medical aspects: clinical testing and marketed product
  • Medical need and pharmacoeconomics
  • Medical cultures
  • Ethnic factors influencing indications, doses, drug regimens, etc.
  • Orphan status
Marketing authorization aspects/strategies: before, during and after marketing authorization
  • Choice of the marketing authorization procedure
  • Development control via regulations (laws, guidelines, recommendations, scientific advice, GMP, GCP etc.) depending on the target regions
  • Quality / content of the dossier
  • Submission schedule
  • Choice of reference country (expertise / cooperation)
  • Documentation protection
  • Pharmacovigilance 
Marketing aspects / strategies
  • Product strategy: pharmaceuticals, foods, nutraceuticals, medicinal products
  • Product presentation / product profile
  • Product position (innovation, line extension)
  • Marketing strategy (co-marketing, co-promotion)
  • Product setting (similar / competitive products)
  • Healthcare policies, pricing, reimbursement
  • Import / export, reimport problems
  • Trade marks
  • Patent situation
  • Life-cycle management
  • Post-marketing surveillance

Study plan

Friday   20 July 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   21 July 2018 from 8.00 a.m. – 4.00 p.m.
Location:   Haus der evang. Kirche, Adenauerallee 37, Bonn
     
    Deadline seminar paper: 20 August 2018

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