EMA

Improving the informed consent process and consent forms can not only help subjects better understand clinical research but also reduce the number of invalid consents obtained.

A newly completed study of European ethics committees finds that the bureaucracy of each country determines the way the ethics committees operate.

After committing itself to researching poverty-linked diseases, the EU is working to decide what responsibilities it has to EU-funded research activities in developing nations.

The latest wrinkle in the European Union?s clinical trials rules debate comes from modifications of the draft text at the core of its proposal.

European organizations express their concerns over the implications of the EU guidances issued in response to the 2001 directive.

The World Summit on Sustainable Development may have fizzled, but a promising new long-term clinical trials partnership between the EU, industry, and developing countries is in the works.

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.

Many stakeholders have already commented on the EU?s incentives for pediatric drug development.

The European Union is working to develop pediatric rules to ensure that medicines prescribed for children are safe, effective, and of high quality.

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.

Facing an immediate future of rapid growth, the EU is looking to clarify its clinical trials policies, but it?s having some problems.

To help protect patient safety and cut red tape, the European Union is working to create tougher standards of pharmacovigilance.

European Parliament debates on the allocation of research funds reveals Euro-MPs views of clinical research in medicines development.

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.

Patients, research companies, and regulatory authorities may all benefit from proposed changes to current pharmaceutical legislation, but the proposals will provoke much debate.

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.