Tag Archives: Europe

The EMA Turns 20: What Does It Want to Be?

Reflector looks at the growing pains of the European Medicine Agency (EMA) as it faces the key policy challenges of 2014. The European Medicines Agency (EMA) is 20 years old this year — and it confronts many of the problems familiar to anyone at that age. After the vigorous growth and boundless optimism of its […]
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Europe: Early Communications with Regulators is Essential for SMEs

With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process. Europe’s regulatory agencies have been stepping up their support for small- and medium-sized enterprises (SMEs), including micro companies, in an effort to stimulate more development of innovative […]
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No Rapid European Turn-Around at the Turn of the Year

By Peter O’ Donnell. It is not only the specific issue of clinical trials rules that hangs in the balance as Europe shifts from 2013 to 2014. Many of the outstanding questions about the European Union’s attempt to update its rules will not be answered until the European Parliament finds time in the new year to […]
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Europe's New Clinical Trials Rules: Questions Remain about Data Transparency

Although a broad compromise was reached in late December on the future shape of the European Union’s clinical trials rules, there are still many details to be resolved – including on that perennial issue of data transparency. In mid-December, Glenis Willmott, the UK socialist who is piloting discussions on the proposal in the European Parliament, […]
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EU Clinical Trials Agreement 'Compromised', Says Industry

European Union (EU) regulators reached agreement today on the much-vaunted Clinical Trials Regulation. The regulation harmonizes the rules for the conduct of clinical trials in the EU and the ‘acceptability’ of the resulting data, and palces further safeguards on the safety of trial subjects. The legislation’s aim is to facilitate and expedite the authorization procedure […]
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