Category Archives: EMA
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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The goal: improvement in safety of medicines
As our life is strongly influenced by the fast growth of the pharmaceutical industry, there is an urgent need for control of their products. Safety of drugs available on the market depends on proper reporting procedures of any adverse drug … 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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