Joint European Medicines Agency (EMA), US Food and Drug Administration (FDA), and Japanese Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) orphan medicinal product workshop

• Date:
  Monday, 10 March 2014, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The aim of the workshop is to provide information to companies, as well as to academics, on the EMA, FDA and MHLW-PMDA systems for orphan medicinal product designation as well as on the grant programmes for development of orphan medicinal products that are available. These programmes aim to promote the development of new medicines for the treatment of rare diseases. This workshop is now fully booked. However, the plenary session will be publicly broadcasted on the EMA website (prior registration not required) - please click on the 'multimedia' tab to watch live on the day. Following the workshop, the recording and presentation slides will also be made available.

Documents

Agenda - Joint EMA-FDA-MHLW-PMDA orphan medicinal product workshop

Presentation - Orphan designation system in Japan (Ministry of Health, Labour and Welfare)

Presentation - FDA Orphan Drug Designation 101 (James H. Reese)

Presentation - Orphan drug designation in the European Union (Stiina Aarum)

Presentation - Grant frameworks: Japan (Hirofumi Kusunoki)

Presentation - FDA orphan products grants program overview (Erica K McNeilly)

Presentation - IRDiRC: EU Research funding for rare disease research (Irene Norstedt)

Presentation - Incentives and regulatory considerations: Situation in Europe (Segundo Mariz)

Presentation - FDA incentives (John D. Milto)

Presentation - Incentives and regulatory considerations in orphan drug/medical device development - Situation in Japan (Hiroshi Takeda)

Presentation - European Orphan Designation: Legal basis (Agnes Mathieu)

Multimedia