May 28th 2025
While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it.
December 7th 2021
Increased public engagement leads recent change in EMA profile.
October 14th 2021
Higher costs headline list of new challenges faced by CROs and sponsors.
February 12th 2021
Cancer still a primary focus of EMA in light of COVID and vaccine development.
January 21st 2021
A Dream Unfulfilled: European Clinical Trials Rules Are Not Working
Leaders in the European regulatory community examine the implications and merits of the EU?s new clinical trials regulations?and find themselves buried in minor details.
Checking In on Children, Checking Up on Files
Many stakeholders have already commented on the EU?s incentives for pediatric drug development.
No Orphans Among European Children?
The European Union is working to develop pediatric rules to ensure that medicines prescribed for children are safe, effective, and of high quality.
Filling in the EU Gaps on Clinical Trials Rules
EU proposals are finally available for the pharmaceutical industry to begin commenting on, and you can bet the industry will take advantage of it.
European Change Is Still in the Air
With the impending expansion of the EU and the revamping of current policies, the pharmaceutical industry is on edge, wanting to know what the future holds.
Forward to 2004 or Back to 1984?
Facing an immediate future of rapid growth, the EU is looking to clarify its clinical trials policies, but it?s having some problems.
Tightening Up European Pharmacovigilance
To help protect patient safety and cut red tape, the European Union is working to create tougher standards of pharmacovigilance.
Europe Looks at Trials in Future Research
European Parliament debates on the allocation of research funds reveals Euro-MPs views of clinical research in medicines development.
Thinking Ahead on Clinical Research
A high-level group explores ways to support EU pharmaceutical industry research without too much cost to the EU health agencies that pay for medicines.
EU Proposes Authorization Changes
Patients, research companies, and regulatory authorities may all benefit from proposed changes to current pharmaceutical legislation, but the proposals will provoke much debate.
Some Do--Some Watch Over Those Who Do
EU regulators try to stay a step ahead of the pharmaceutical industry, and the industry keeps a wary eye on Europe's evolving regulatory environment.