Qdossier presenting on Regulatory Strategies for Orphan Drugs

On September 26th, Qdossier will present a 1-day training course which is part of the Management Forum training curriculum. The interactive course will cover all the key aspects of orphan drug legislation in both the US and EU and the regulatory strategies/processes designed to enable early access to innovative medicines. During this training  you will:

• Gain an overview of the orphan medicinal product legislation in the EU and the US
• Receive practical advice on how to prepare and manage orphan submissions
• Assess strategic considerations of when to apply for orphan designation and to what agencies
• Discuss the use of orphan drug designation with your ATMP strategy

Find more information on the event here

Speaker: Marloes van der Geer