Tag Archives: pharmacovigilance

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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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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European Pharma Must Get Its Data in Order

New data maintenance guidelines have sparked a flurry of activity in Europe. Organizations are still grappling with electronic submissions, and the need to update data is intensifying the pressure. But there is an upside, says Miranda Pothiawala. Earlier this year formal guidelines on how to maintain and update data submitted to the extended EudraVigilance Medicinal […]
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Industry Takes EU to Task Over Pharmacovigilance Fees

Europe’s leading pharma industry bodies — EFPIA, EGA, EuropaBio, AESGP and EUCOPE — have issued a joint statement to express concern about “the increasing financial burden of regulatory costs incurred since the adoption of the pharmacovigilance package in 2010″.  Procedural fees such as for pharmacovigilance referrals, they argue, have been significantly increased in the last […]
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Thinking of Phase IV Trials? Europe Might See Things Differently…

By Peter O’ Donnell. With the shadow cast by Mediator across Europe now receding to a focus on the French law courts, the European Union (EU) said in late November that its pharmacovigilance arrangements offer “one of the most advanced and comprehensive systems in the world”. Certainly the EU’s legislative framework has been significantly boosted […]
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