View from Brussels

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

Articles

Europe trade and lobby group says implementation issues related to the legislation could impact 420 trials—and 42,200 patients—over the next three years.

EFPIA: Trials Hampered by New Rules on In Vitro Diagnostics

Latest project centers on partnership to align PM innovation with sustainable healthcare. 





Is Europe Inching Toward a Common Approach to Personalized Medicine?

Reformed EMA looks to tackle challenges in drug development, pediatric medicines, and unmet medical need.

Hints on Looming Changes to European Clinical Trial Rules

The Association of the British Pharmaceutical Industry greets the development with mix of relief and urgency.

UK Gov’t Offers a ‘Review’ Amid Clamor Over Declining Clinical Research

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.