Tag Archives: Clinical Trials

EU Clinical Trials Rules: One Step Closer But Not Yet a Done Deal

By Peter O’ Donnell. To believe the European Parliament, the battle to create new clinical trials rules for the European Union is over. On January 22, the parliament’s health committee adopted the draft report prepared last year by one of its leading members. “Clearer rules, better protection for patients,” trumpeted the parliament’s press machine after […]
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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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No Rapid European Turn-Around at the Turn of the Year

By Peter O’ Donnell. It is not only the specific issue of clinical trials rules that hangs in the balance as Europe shifts from 2013 to 2014. Many of the outstanding questions about the European Union’s attempt to update its rules will not be answered until the European Parliament finds time in the new year to […]
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Pharma Must Adopt New Development Paradigms, Says Tufts Report

Change has never been the word most associated with pharma. Irrespective of a record-breaking number of newly approved drugs over the last two years, a new report just out warns that continued growth is not sustainable unless R&D efficacies at drug companies are addressed and new paradigms adopted. As clinical trials continue to improve their […]
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Europe's New Clinical Trials Rules: Questions Remain about Data Transparency

Although a broad compromise was reached in late December on the future shape of the European Union’s clinical trials rules, there are still many details to be resolved – including on that perennial issue of data transparency. In mid-December, Glenis Willmott, the UK socialist who is piloting discussions on the proposal in the European Parliament, […]
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