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

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TitleJoint 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
Date10/03/2014 - 10/03/2014
LocationEuropean Medicines Agency, London, UK
SummaryThe 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.

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Contact point:

Contact at EMA: orphandrugs@ema.europa.eu

Contact at FDA: eleanor.dixon-terry@fda.hhs.gov

Contact at MHLW/PMDA: nitta-akiko@pmda.go.jp