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Clinical Trials Regulation (EU) No 536/2014

Clinical Trials Regulation (EU) No 536/2014

The Regulation on Clinical trials on Medicinal Products for human use (Regulation (EU) No 536/2014 of the European Parliament and of The Council of 16 April 2014) has been published in the Official Journal of the European Union. This Regulation will replace the...

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EMA FDA bilateral meeting

EMA FDA bilateral meeting

Representatives from DG Health and Consumers (European Commission), European Medicines Agency (EMA) and the American agency Food and Drug Administration (FDA) discussed a number of key initiatives at a bilateral meeting which took place in London from 31 March to 1...

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InNerMeD-I conference on Inherited neurometabolic diseases

InNerMeD-I conference on Inherited neurometabolic diseases

The first InNerMeD-I-Network Open Conference was held in Frankfurt on March 7th – 9th, 2014 (attached the scientific programme of the workshop). The meeting was aimed to enable the exchange of information among clinicians, basic scientists, experts specialised on...

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International Master in Regulatory Science launched

International Master in Regulatory Science launched

The first International Master on Regulatory Science has been presented on the 1st of March 2014 in Samsun (Turkey), in the framework of the workshop on internationalisation of Higher Education. The Master, with duration of one year, is promoted by Fondazione Gianni...

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New edition of the Master in Regulatory Science launched

New edition of the Master in Regulatory Science launched

The new edition of the two-year Master in Regulatory Science "G.Benzi", organised by the University of Pavia, has been launched. The Master, involving as teachers highly qualified experts and professors from different universities, aims to train new experienced...

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EMA grants PUMA for hemangiol under paediatric regulation

EMA grants PUMA for hemangiol under paediatric regulation

For the second time since the entry into force of the Paediatric Regulation (Reg. EC 1901/2006), the European Medicines Agency (EMA) has granted a positive opinion for a paediatric-use marketing authorisation (PUMA). The object of the opinion is Hemangiol, a drug for...

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The website for InNerMeD-I-Network is now online

The website for InNerMeD-I-Network is now online

The website dedicated to the project InNerMeD-I-Network  is now available online. The website, accessible to the public thanks to an easy-to-use interface, is aimed to disseminate all the project activities and its results. Here, you can also download the electronic...

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