Tag Archives: Europe

The Year of Living Openly: Europe and Transparency 2015

The past year has brought significant changes not only in regulatory mandates and guidances but also regarding a broader overall emphasis on coordination of information and processes. The regulators have prioritized transparency and harmonization for some time but underscored them to an even greater degree in 2014; 2015 is likely to see the trend intensify.
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So Who’s in Charge of Medicines in Brussels?

So now we know who is to do what on health issues in the new European Commission. Or do we? The furor that the new boss of the commission, Jean-Claude Juncker, unleashed with the plans for his new team, weeks before it took office, is still reverberating around Brussels. Peter O’ Donnell reports on the […]
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EFPIA Promises Stronger Ties with China

The European Federation of Pharmaceutical Industries and Associations (EFPIA) reports that it has “strengthened its commitment in China”. Federation delegates are this week concluding a visit to Beijing to establish “a better understanding of the numerous healthcare reforms underway in China … and explore closer paths of cooperation in global drug development between China and […]
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European Pharma: Paying the Price of Pharmacovigilance

Pharmacovigilance controls are becoming firmly embedded in the European Union’s post-authorization regulatory system, with the European Medicines Agency (EMA) acting as the pivot for an EU-wide network of agencies monitoring medicines throughout their market lifespan. The new pharmacovigilance activities stemming from the EU legislation, the first stage of which was approved four years ago, relate […]
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The Transatlantic Trade and Investment Partnership: From Hot TTIP to Oblivion?

Only a year ago, hopes were high of rapid progress towards a transatlantic trade deal that would boost the European and US economies — and ease conditions for drug firms on both sides of the ocean. TTIP, the Transatlantic Trade and Investment Partnership, was the hot tip for a 2014 success story. But as summer […]
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