Tag Archives: Europe

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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EuropaBio’s Most Innovative Biotechs 2014

EuropaBio, the European Association for Bioindustries, has announced its “top five biotech SMEs in Europe”. The companies will compete to win the 5th annual Most Innovative EU Biotech SME Award, to be awarded during European Biotech Week (October 8) in Brussels, Belgium. Shortlisted are: 
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Major Changes to EU Clinical Trials Regulation

Earlier this year, the newly approved EU Clinical Trials regulation (No 536/2014) was published in the Official Journal of the EU (OJEU).  The European Commission (EC) estimates that all the changes could save researchers €800 million (over $1 billion) a year. It replaces the existing EU Clinical Trials Directive (2001/20/EC), which was intended to simplify […]
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European Pharma Races to Catch Up with Data Protection

The European Union’s struggle to bring its data protection rules into the 21st century continues—haltingly—as the EU itself enters its new era, with a new European Parliament, a new President-designate of the European Commission, and a new European Commission due to take office in November. This has left the pharmaceutical sector, already out of breath […]
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