Regulatory Strategies for Orphan Drugs
The market for orphan drug products continues to expand and developing new treatments for rare diseases is becoming an increasingly important growth area for many pharmaceutical companies. This interest in rare and orphan diseases is linked not only to the incentives offered by the different regulatory authorities but also to the recent development of advanced therapies.
The interactive course will cover all the key aspects of orphan drug legislation in both the US and EU, including a review of changes proposed in the revised EU orphan drug legislation, and the regulatory processes designed to enable early access to innovative medicines. The programme will help you to assess the strategic considerations of when to apply for orphan designation and to which agency and look at the development of advanced therapies and using orphan drug designation with your ATMP strategy.
A case study session on how to prepare and manage an orphan drug submission will consolidate learning and ensure that you leave the event with practical skills and knowledge that can be put to use in the workplace. The course will allow you not only to learn from our expert trainer but also to share the experiences of other delegates.
Benefits of attending:
- 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
Upcoming start dates
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Reviews by course attendees
Average rating 4.4
Very instructive training with a very nice speaker. Speaker knew her subject very well and she was able to share some of her experiences with ODD which made the training more in...
Everything was OK
I believe as a starting point into the world of ODD this was very comprehensive and informative. Very clear and concise.