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