Product/Service
Future Direction For Orphan Drugs In Europe
Event Brochure: Future Direction For Orphan Drugs In Europe
Date(s) And Time(s):
Nov 3 2010 8:00AM - Nov 3 2010 5:30PM
Location:
Radisson Blu Hotel Paris Charles De Gaulle Airport
Rue de La Chapelle
Le Mesnil Amelot
77990 Paris
France
Interest Area(s):
Regulatory Affairs, Research & Development, Strategic Planning, Advertising & Promotion
Overview:
This 1st DIA conference on Orphan Drugs will reflect on the experience gained in the first 10 years of the European Orphan Medicinal Products (OMP) Regulation. It will review current developments in orphan drug research, look at points of collaboration between regulatory and HTA bodies and provide an outlook on future developments.
Since the adoption of the EU's OMP Regulation, more than 60 new medicines have received a positive opinion for EU Marketing Authorisation, more than 700 orphan designations have been granted and, along the way, a huge body of experience and expertise has been built up in the EU.
We will soon be 2 years on from the High Level Pharmaceutical Forum's conclusions and recommendations on Orphan Drugs; and, additionally, 2 years on from the publication of the European Commission's Communication on "Rare Diseases: Europe's Challenges". The European Medicines Agency's Road-Map to 2015 is under discussion and the European Commission's DG SanCo is formally looking into potential methodologies for conducting a common assessment of the Clinical Added Value of Orphan Drugs and examining ways in which Member States can cooperate to share information in order to increase access to orphan drugs.
So to what extent have the expectations of stakeholders – rare disease patients, regulators, governments, researchers, industry and payers – been met? What incentives are in place for research institutes and companies to research and develop orphan drugs? How will existing European rules interact with current initiatives to facilitate uniform access to rare disease patients for innovative treatments which work?
The time is right to look into where we are and where we are headed – this workshop will provide the opportunity for all stakeholders to come together and review the key opportunities and challenges for the coming years
Click Here To Download:Event Brochure: Future Direction For Orphan Drugs In Europe
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