View from Brussels

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

Articles

EMA opens public discussion on envisioned platform to encourage multi-stakeholder interactions and shared understanding.

EU Seeking Wider Views in Its Push to Promote Clinical Trials

The issues engulfing compliance with the Clinical Trials Regulation signal that even the best  intentions with these types of laws may not be enough to avert unintended consequences.

Get it Right Next Time? EU Legislation Under Critical Review

WHO in midst of forming group focused on developing guidance on best practices in clinical trials.

A New Year, a New Clinical Trials Committee—with Global Reach

With compliance deadline at end of month, concerns over readiness remain.

Countdown to Mandatory European Clinical Trials System

Despite agreement on recommendations between European regulators, DCT unclarity remains.

Decentralized Guidance Is the Best That Europe Can Do for Decentralized Clinical Trials

Debates caught between focusing on existing antibiotics and developing new agents.

Europe’s Debate on AMR Becomes Another Proxy War Over Money

The Sudan Ebola virus outbreak in Uganda spotlights this dilemma in responding to public health crises.

What if Clinical Trials Deliver Results Too Late for an Emergency?

Inaugural group of members added to EMA’s new data network focused on RWE.

Real-World Evidence Makes Further Headway in Europe’s Healthcare Planning

New guidance to drill down on more specifics in hopes of harnessing the growth of these types of studies. 


Bringing Further Certainty into Platform Trials in Europe

Rare disease stakeholders speak out ahead of anticipated EU changes.