Value Added Medicines
23.08.2018 15:13
Reformulation, repurposing, repositioning - in this course you will learn about the options and possible hurdles to overcome in the development, regulatory affairs and market access of your drug.
Termindetails
Wann
22.11.2018
von 09:00 bis 17:00
von 09:00 bis 17:00
Wo
Düsseldorf
Kontakttelefon
+49 6221 500-680
Teilnehmer
This course addresses the needs of all those working with reformulated, repurposed or repositioned drugs, particularly in drug development, business development, regulatory affairs and market access.
Reformulation, repurposing, repositioning - these are some of the options available for known substances, to develop and sell value added medicines.
This course focuses on the development, regulatory affairs and market access activities in creating and selling these pharmaceuticals in Europe (and beyond).
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?).
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 des Seminars:
- 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
- Repurposing existing marketing authorisation dossiers
- Drug repurposing vs drug discovery
- Pitfalls of clinical development
- Drug repurposing and IP protection
- Challenges when leaving the EU
