Ten years of the Orphan Regulation in Europe

• Date:
  Monday, 3 May 2010, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The European Medicines Agency is holding a conference to celebrate the results of the implementation of the Orphan Regulation in Europe. The conference is bringing together patients, researchers, industry and regulators to discuss and share experiences with the development of orphan medicinal products.

Documents

Gene therapy-based orphan drugs: Alessandro Aiuti

A Regulation addressing the needs for drug development in rare diseases: Martin Terberger, Mirjam Sà¶derholm

What has changed for drug development?: Kerstin Westermark

10 years of the Orphan Regulation in Europe conference - The experience up to date: S. Aarum, S.Tsigkos

Collaboration and exchange of information between the COMP and the Paediatric Committee

Collaboration between COMP and CHMP: Patrick Salmon

Is the Orphan Regulation addressing patient needs?: Yann Le Cam

Pharmaceutical Industry Perspective: Dr. Catarina Edfjà¤ll

Orphan Regulation - The Academic View

Rare metabolic diseases, the miglusat experience: Fran Pratt

EU initiatives for research on rare diseases: Charles Kessler

Public Health Impact of the Orphan Drug Regulation: Sà©golà¨ne Aymà©

The next 10 years: Focal Points from the Industry: Dr. Erik Tambuyzer

The next 10 years: A regulatory view: Jordi Llinares