9th Annual Biomarkers Congress
Future Direction for Orphan Drugs in Europe
Radisson Blu Hotel Paris Charles De Gaulle Airport

Le Mesnil Amelot, Paris
http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23718&eventType=Meeting
 This conference will reflect on the experience gained in the first ten
   years of the European Orphan Medicinal Products regulation and provide
   an outlook on future developments. Learning and outcomes from the
   European Medicines Agency ten year celebration conference on Orphan
   Medicinal Products will also be shared. Target Audience: The aim of
   this one day conference is to bring together patients, academia,
   researchers, industry and regulators to share experiences with the
   development of orphan medicinal products in Europe. Opportunities and
   challenges will be discussed while addressing various aspects from
   designation to market access of orphan medicinal products. Event Code:
   10117

Schedule of Presentations:

Wednesday, November 3, 2010
08:00:00 Registration
09:30:00 ORPHAN DESIGNATION: WHAT HAVE WE LEARNT AND WHAT HAS CHANGED IN THE COURSE OF THE FIRST 10 YEARS? Kerstin Westermark, Jordi Llinares
09:35:00 Successful orphan drug development – a EU and US analysis Harald Heemstra
10:00:00 What Have We Learnt – Agency Perspective Jordi Llinares
10:30:00 Orphan Drugs in Europe: Past, Present and Future, An Industry Perspective Catarina Edfjaell
11:00:00 MARKETING AUTHORISATION FOR ORPHAN DRUGS: SIGNIFICANT BENEFIT, SIMILARITY, MARKET EXCLUSIVITY AND OTHER CHALLENGES Patrick Salmon, Catarina Edfjaell
11:05:00 Orphan Designation and Significant Benefit Rembert Elbers
11:30:00 Industry Experience Henk F. Schuring
12:00:00 Lunch
13:30:00 OPPORTUNITIES AND CHALLENGES IN ORPHAN DRUG RESEARCH AND DEVELOPMENT Lesley Greene, Emmanuel Chantelot
13:35:00 Rare Disease Research in Europe: Trends and determinants
14:00:00 Unmet Medical Needs Lesley Greene
14:30:00 The FDA Perspective Katherine I. Needleman
15:30:00 MARKET ACCESS AND HTA: PARTICULAR CHALLENGES AND OPPORTUNITIES FOR ORPHAN DRUGS GENERATING THE LEVEL OF EVIDENCE NEEDED FOR DECISION MAKING ON THE VALUE OF ORPHAN DRUGS IN THE THERAPEUTIC STRATEGY OF A RARE DISEASE Wills Hughes-Wilson, Yann Le Cam
15:35:00 The Clinical Added Value of Orphan Drugs and Current State of Play Wills Hughes-Wilson
16:00:00 What Could be the Benefit Management Plan for Orphan Drugs Hans-Georg Eichler
17:00:00 Adjorn
4th Annual Pharma R&D Asia Congress
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