Category Archives: European Union

The EMA and Foreign Data_Part 2

Previously we looked at data from the European Medicines Agency, which showed the increasing role since 2005 that some ‘Rest of the World’ nations were playing in enrolling patients in clinical trials supplying pivotal data for marketing authorisation applications (MAAs) … Continue reading

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The EMA and Foreign Data_Part 1

In recent years we have seen an increase in the number of trials conducted for EU marketing authority applications (MAA) in areas other than what was considered to be in the two main European [European Union (EU) / European Economic … Continue reading

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Brexit and Clinical Trials_Part 2

What are the implications and consequences of the Brexit vote for the pharmaceutical and MedTech industries so close to the heart of most reading this piece? Many in these industries and in academic research establishments argued that a Brexit vote … Continue reading

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Brexit and Clinical Trials_Part 1

Well, the people of Britain have now spoken – albeit not that clearly given a 51.9%:48.1% split in the referendum voting figures. Nevertheless, it’s a democratic decision and now the word on almost everyone’s lips is “Brexit”. Despite a protest … Continue reading

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New EU Trial Regulations – Time Will Tell……

All those engaged in trials within Europe should be familiar – at least to some degree if not intimately – with the ‘Clinical Trials Directive’ (or to give it its full, and understandably seldom used, full document title: ‘Directive 2001/20/EC … Continue reading

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New EMA policy on access to clinical trial data – still a hot topic

Transparency of data is paramount to scientific communities worldwide and a sine qua non for the unbiased technological advancement. This, naturally, also refers to scientific research in medicine. As we read on through the European Medicines Agency’s (EMA) mission and responsibilities, … Continue reading

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Get ready for ESC 2014 – the Europe’s greatest cardiology event

At Clinical Accelerator, we are getting excited about the European Society of Cardiology conference, which is to be held in Barcelona next week and has the theme “innovation and the heart”. The excitement focuses on the late-breaking trial results of … Continue reading

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