Mark your calendars !!
Plan on attending a workshop on orphan product designation and grants organized by the following three regulatory agencies :
• European Medicines Agency (EMA)
• US Food and Drug Administration (FDA)
• Japanese Ministry of Health, Labour, and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA).
The joint EMA/FDA/MHLW-PMDA Orphan Medicinal Product Workshop is scheduled for March 10, 2014, at the EMA, in London (UK). There is no registration fee for attending, but registration is required. One can register online. The meeting Agenda is available.
The purpose of the workshop is to provide information, about the EMA, FDA, and MHLW-PMDA regulatory agencies, requirements for orphan product designations, and information on grant programs available for the development of orphan products. The goal is to encourage and promote the development of new orphan products for rare diseases.
The workshop’s morning session will provide information about the EMA, FDA, and MHLW-PMDA…
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DRUG REGULATORY AFFAIRS INTERNATIONAL 