Peter O’ Donnell


Clinical Trials in Europe: Dragging the New Rules into Operation

The entry into force of the new EU clinical trials regulation last June is really little more than a virtual event. The new rules will apply only once the EU Clinical Trials Portal and Database now under development are fully operational.

Adaptive Licensing: The Start of a Slow Revolution in Europe

So at last it’s happened. Adaptive licensing has leapt from the pages of learned journals into the real world of European regulation.

Europe: Expectations High for Rare Disease Day

This week (February 28), Europe will celebrate Rare Disease Day. This is an interesting example – one might almost say a rare example – of a successful attempt by a European interest group to capture public attention.

How Good for UK Pharma is the European Union?

As the United Kingdom debate about whether to stay in the European Union becomes more bitter and intense, an insight into how EU membership impacts on medicines and pharmaceuticals has appeared from a British politician who was until recently the UK Government Adviser on Life Sciences, George Freeman.

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.