Value Added Medicines

Reformulation, repurposing, repositioning - these are some of the options available for known substances, to develop and sell value added medicines.
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This course focuses on the development, regulatory affairs and market access activities in creating and selling these pharmaceuticals in Europe (and beyond).
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Day one will familiarise you with the regulatory challenges of the marketing authorisation and the necessary expertise to overcome the development hurdles (PIP required? IP protection?).
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Day two initially focuses on analytics and strategic planning, then on pricing and reimbursement, which help you answer the crucial question: 'Does the repurposed or repositioned drug receive appropriate reimbursement in Europe?'

Themen

- Old marketing authorisation dossier: Is it fit for new markets in the EU?
- Repurposing existing marketing authorisation dossiers
- Drug repurposing vs drug discovery
- Pitfalls of clinical development
- Drug repurposing and IP protection
- Challenges when leaving the EU