Tag Archives: Europe

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 […]
Posted in Europe, Guest Blog, healthcare, Regulatory | Also tagged , , , | Leave a comment

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, […]
Posted in Europe, Global, Guest Blog, Regulatory, Safety | Also tagged , , , | Leave a comment

EU Clinical Trials Agreement 'Compromised', Says Industry

European Union (EU) regulators reached agreement today on the much-vaunted Clinical Trials Regulation. The regulation harmonizes the rules for the conduct of clinical trials in the EU and the ‘acceptability’ of the resulting data, and palces further safeguards on the safety of trial subjects. The legislation’s aim is to facilitate and expedite the authorization procedure […]
Posted in Europe, Global, R&D, Regulatory | Also tagged , , , | Leave a comment

Europe: EMA and EUnetHTA Agree Three-Year Work Plan

By Leela Barham. Collaboration seems to be ‘in’ thing and it’s set to continue in Europe with the European Medicines Agency (EMA) and EUnetHTA agreeing a three-year joint work plan.
Posted in Europe, Global, Guest Blog, healthcare, Strategy | Also tagged , , , , | Leave a comment

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 […]
Posted in Europe, Global, Guest Blog, Op-Ed, R&D | Also tagged , , , | Leave a comment
  • Categories

  • Meta