Tag Archives: European Union

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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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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EMA Sets Budget and Priorities for 2014, Promotes Transparency

In a bid to improve transparency in 2014, the European Medical Agency’s December Management Board Meeting cleared the way for the publication of the agendas and minutes of the Agency’s Committee for Medicinal Products for Human Use (CHMP), Committee for Medicinal Products for Veterinary Use (CVMP) and Committee for Advanced Therapies (CAT). This week the EMA […]
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