Category Archives: Guest Blog

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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Industry Growth Slowdown in Brazil

By Hellen Berger. The Brazilian economy is being impacted by internal and external factors, and forecast figures are being quickly revised downwards. Market research released by Brazil’s Central Bank revised average analysts’ projections for economic growth in 2014 down to 0.70% from 0.90% four weeks earlier(1). In June 2014, the Hong Kong Trade Development Council […]
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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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Meeting Patient-Centered Expectations in Europe

By Peter O’Donnell, Applied Clinical Trials. The growing insistence on making healthcare more patient-centered — Europe is currently awash with declarations of intent along those lines — is generating a new level of interest in helping patients (or even citizens) to meet the expectations that the new orthodoxy is creating. After all, there is little logic […]
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We Need to Rock the Boat to Make Research Soar

By Wayne Kubick, Applied Clinical Trials. We hear it all the time these days: research processes have to undergo transformative changes in order for research organizations to thrive—or even survive. Controlled clinical trials take too long and cost too much. Regulatory review is blocking innovation. Research data must be shared transparently, drug manufacturers need to […]
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