Tag Archives: Europe

EFPIA's "Integrated Strategy": Out of the Frying Pan, Into the Fire?

It’s difficult to open an email or an envelope in Brussels these days without yet another agenda falling out of it, carrying the promise of a new start. With a new European Parliament installed, a new European Commission president appointed and a new Commission on the way, and guarded optimism that the worst of the […]
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Further Boost for Europe’s Largest Healthcare Partnership

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has announced the launch of IMI2, with a budget of €3.3 billion (US$ 4.5 bn). IMI (the Innovative Medicines Initiative) is a public-private partnership (PPP) between the European Commission and EFPIA, and was already the largest healthcare PPP in Europe. The budget for its first phase (2008-2013) […]
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Eight Lessons for Enhancing Compliance Effectiveness in Europe

Andy Bender and Geert van Gansewinkel outline eight lessons for executing a soft change program for enhancing compliance effectiveness within European life sciences organizations. The European compliance and transparency landscape has changed rapidly over the last couple of years. Over and above the challenging compliance landscape, there is additional complexity impacting transparency relating to the […]
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US Regulators and Industry Bodies Push Forward with Global Expansion

At the annual meeting of the Food and Drug Law Institute (FDLI) this year, FDA commissioner Margaret Hamburg concluded her keynote address by describing a “dramatically changing global marketplace” and its “huge implications” for FDA’s ability to ensure the safety and quality of products manufactured elsewhere. In addition to conducting more inspections and oversight of […]
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Europe Sees Pressure to Reduce Environmental Impact of Pharmaceuticals

Pressure is mounting on European legislators to introduce tighter regulations at both the European Union (EU) and national levels on the potentially harmful impact of pharmaceuticals on the environment. Politicians, environmentalists and even medicines regulators are calling for action in the face of increasing evidence that pharmaceutical chemicals used through the whole lifecycle of medicines […]
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