Module Head: Dr. Josef Hofer

	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