Registration open for orphan-product-designation and -grant workshop

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Registration open for orphan-product-designation and -grant workshop

Registration is open for the orphan-product-designation and -grant workshop. Organised by the United States Food and Drug Administration (FDA), the aim of the workshop is to provide information on the European Medicines Agency (EMA) and FDA programmes for orphan-medicinal-product designation, as well as on the FDA programmes for orphan-product grants and humanitarian-use device designation to pharmaceutical, biotechnology and device companies, as well as to academics.

The event will be held on Friday 4 October 2013 at the FDA White Oak Campus in Silver Spring, Maryland, United States.

The information session will be held between 8.30am and 10.45am Eastern Standard Time and will be webcast on the FDA website.

The afternoon session will be dedicated to one-to-one meetings with EMA (by teleconference) and FDA staff, during which participants will have the opportunity to present draft applications based on a medicine under development that holds promise for the treatment of a rare disease.

These one-to-one sessions are intended to help participants improve their applications to ensure that they fulfil the requirements of EMA and FDA procedures and increase their chances of obtaining an orphan designation for their medicine in the European Union (EU) and the United States.

There is no registration fee for attending the workshop, although participants do need to register for both morning and afternoon sessions at FDA orphan-product-designation and -grant workshop.

Registration is limited to 240 participants for the morning session. Up to 50 teams formed of one to three participants can register for the one-to-one sessions.

The workshop is being conducted in partnership with the European Organisation for Rare Diseases (EURORDIS), Genetic Alliance and the National Organization for Rare Disorders (NORD).

International cooperation on orphan medicines

This is the third year that this workshop has been held. It is organised as part of a broader initiative to expand active international cooperation in the area of orphan medicines.

The EMA and the FDA started collaboration in 2008, allowing applications for orphan-medicine designations to be submitted in parallel to the two agencies. The parallel submission process helps rationalise the development of orphan medicines by facilitating access to parallel scientific advice or protocol assistance from the two regulatory authorities.

Based on the success of this collaboration, which led to parallel submission for 62% of dossiers submitted to the EMA in 2012, the EMA began to collaborate with the Japanese regulatory authorities last year. On 19 September 2013, the EMA is holding a meeting at the Embassy of Japan in London to explain the EU orphan-medicinal-product regulation to Japanese companies based in Europe.

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