A road map for orphan drugs in Europe and the US

Save the date for a seminar that will give practical insights on how to address regulatory and market access questions that an orphan drug will face on the way to market in Europe and the USA.

The seminar will be hosted by Karolinska Institutet Innovation and will address topics such as:

• The EU legal framework and steps after orphan drug designation to ensure that orphan status is maintained at the marketing stage and following addition of new indications by variation.

• The importance of scientific advice/protocol assistance and specifically to discuss questions of significant benefit. Potential role of the Innovation Task Force.

• Market exclusivity issues in the EU including what constitutes a “similar product” and issues that arise in relation to rewards for paediatric research where orphan designation is surrendered.

• New US legislation on orphan drugs.

• Pricing/reimbursement trends (and new/innovative models/schemes) for orphan drugs seen in Europe and the US.

• Strategies at the market access stage in Europe and the US (for example, “do’s and don’ts” when having parallel discussions with different European pricing/reimbursement counterparts).

Speakers that will participate in the seminar are: Lincoln Tsang and Ian Dodds-Smith (partners, Arnold & Porter Kaye Scholer LLP, London), Dan Kracov (partner, Arnold & Porter Kaye Scholer LLP, Washington D.C), Per Hedman and Anders Burén (partner and senior counsel, Lindahl, Stockholm) and Göran Arvidsson (CEO, Hansa Medical).

Download the PDF-invitation.

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