Tag Archives: European Union

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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EU Clinical Trials Rules: One Step Closer But Not Yet a Done Deal

By Peter O’ Donnell. To believe the European Parliament, the battle to create new clinical trials rules for the European Union is over. On January 22, the parliament’s health committee adopted the draft report prepared last year by one of its leading members. “Clearer rules, better protection for patients,” trumpeted the parliament’s press machine after […]
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The European Regulatory Outlook for 2014

Pharm Exec’s EU correspondent, Reflector, looks at some of the European regulatory developments earmarked for 2014 and anticipates their effect on the industry. Personnel Some of the big influences on the pharma industry in Europe next year — and for several years to come — will be the big changes upcoming in key personnel in […]
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Europe's IMI Looks to Portugal and Finland to Lead Scientific Committee

Europe’s Innovation Medicines Initiative (IMI) has appointed experts from Portugal and Finland to chair the IMI Scientific Committee. Professor Maria Beatriz da Silva Lima of the University of Lisbon in Portugal will be the new Chair; Professor Markus Perola of Finland’s National Institute for Health and Welfare was appointed Vice Chair. The IMI is the […]
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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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