Category Archives: Europe

The Year of Living Openly: Europe and Transparency 2015

The past year has brought significant changes not only in regulatory mandates and guidances but also regarding a broader overall emphasis on coordination of information and processes. The regulators have prioritized transparency and harmonization for some time but underscored them to an even greater degree in 2014; 2015 is likely to see the trend intensify.
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EMA Revises Conflict-of-Interest Policy

The European Medicines Agency (EMA) has published its revised policy on handling declarations of interests for scientific-committee members and experts. The revisions strive for a more balanced approach in restricting the involvement of experts with possible conflicts of interests in the Agency’s work, while maintaining access to expertise.
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No-One's in Charge of Pharmaceuticals in Europe!

Peter O’Donnell’s recent Applied Clinical Trials blog, ‘Who’s in charge of Medicines in Brussels?‘, has been overtaken by history, with the departure of Guido Rasi from his post of Executive Director of the European Medicines Agency. At a time of flux in the European context for pharmaceuticals, Rasi’s moderate manner and capacity for strategic thinking […]
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EMA States Position on Confidential Information

In response to a letter the European Medicines Agency received from the European Ombudsman on Oct. 27, 2014, the agency is clarifying its policy on commercially confidential information. EMA states in its response that the agency is responsible for ruling on redactions of published documents and bases its decisions in accordance with laws and internal […]
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Germany Post AMNOG

While emerging markets continue to represent a new channel of demand for pharmaceutical products, manufacturers have quickly realized that significant attention must still be given to more established markets, such as Germany. It’s no longer sufficient to expect that regulatory data from prospective randomized clinical studies alone will be enough to convince payers to provide […]
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