Tag Archives: Europe

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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Pharma Should be at Heart of European Economic Reform, says EFPIA

The European Federation of Pharmaceutical Industries and Associations (EFPIA) yesterday launched what it called “a landmark paper” outlining steps towards an integrated strategy for the life sciences sector in Europe. “Health & Growth — Working together for a healthy Europe” calls for a new generation of partnerships to address the EU’s growing health and competitiveness challenges. The […]
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European Pharma Launches Strategy Manifesto

Europe’s pharma industry association EFPIA has launched its ”Manifesto for an Integrated Life Sciences Strategy in Europe”. The manifesto is built on three “separate but highly interdependent pillars”: 1. Improve health outcomes & remove inequalities to better patient benefits; 2. Support sustainable & predictable healthcare systems to speed access to medicines; 3. Build a thriving innovative […]
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