Author Archives: Reflector

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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Clinical Trial Data Disclosure in Europe: EMA Biting Off More than It Can Chew?

Is the EMA biting off more than it can chew? Reflector The European Medicines Agency’s ambitions are huge – as befits a body with such huge responsibilities. But its capacities to achieve what it sets out to do are now falling ever shorter. The latest deficiency is revealed by its admission that it cannot meet […]
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Who Dares to Stop the European Transparency Bandwagon?

Who is Trying to Stop the European Transparency Bandwagon? Reflector, EPE, October 14 2013 The data-transparency bandwagon is rolling rapidly across Europe, energetically propelled by regulators, health campaigners, and generic manufacturers. Much of the research-based industry is stepping out of the way of what looks like an unstoppable juggernaut, hoping at best to nudge it […]
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Europe: New Device and Diagnostics Legislation Could Shake Up the Drug Industry

EuropeNew Device and Diagnostics Legislation Will Shake Up Drug Industry The shockwaves from the current European Union debates in Brussels on medical devices are are likely to echo through the medicines business over the next few years. This month, the European parliament’s health committee will reach its view on the two major proposals launched last […]
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Testing the Waters of Transatlantic Trade

Testing the Waters of Transatlantic Trade As the process gets underway to create the Transatlantic Trade and Investment Partnership (T-TIP), Reflector asks, what is the likelihood of drug firms – and patients – reaping any rewards from the negotiations? So ceremonial was the launch in July of the wide-ranging EU-US trade talks that one might […]
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