- How can you make sure your lead orphan drug gains regulatory approval?
- How and when should you engage in open dialogue with the regulatory agencies in the EU, US and emerging countries?
- How can you gain accelerated review to avoid delayed market access to the patients in need?
Attend the World Orphan Drug Congress 2011 in Geneva on the 29th November – 1st December and learn what type and quantity of clinical information is required to meet regulatory standards. Identify the regulatory hurdles and engage with pioneers of the orphan drug community who have a proven track record in overcoming them.
Hear David Aviezer, President & CEO, Protalix Biotherapeutics deliver exclusive insight on the regulatory expectations and clinical strategy implemented to treat Fabry disease.
Learn from Martine Zimmermann, Executive Director Regulatory Affairs, Alexion Pharmaceuticals as she presents best practice for communicating with regulators early in drug development and harnessing their feedback to gain approval.
Download the presentation delivered last year at the World Orphan Drug Congress by Dr Remco de Vrueh, Orphan Product Development, Dutch Steering Committee for Orphan Drugs: Explaining what is critical for successful market authorisation
Make sure you attend to get face-to-face time with the orphan drug policy-makers, and have your say in the future of the rare disease industry.
The World Orphan Drug Congress 2011 team