Blogs

The questions and uncertainties that surround electronic patient reported outcomes in Europe.

A look at the directive's flaws and the differing views across Europe about how to fix it.

Drug evaluation criteria could soon include an intrusive health technology assessment.

Attention turns to its ederly population and their lack of participation in clinical research.

EMEA responds to more medicines, increase in complex procedures, and plethora of committees.

The management board has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director, and the monitoring of the Agency's performance.

Health concerns require EU regulators to become more involved in the politics of health care.

The EU struggles to get over its regulatory hurdles in an effort to further R&D success.

The globalization of clinical research leads both sides of the Atlantic to collaborate on GCP inspections.

Contradicting decisions call for a unified clinical trial authorization process.

European Union health ministers begin reviewing proposals to better adverse event assessment in Europe.

EMEA releases new guideline for studies in PTSD, as new figures depict a lagging EU.

Changing rules on advanced therapy medicinal products to require more from clinical studies.

As EU debates plans for advancing R&D in rare diseases, industry assesses the risks and benefits.

Ten-year-old study sets precedent for future collaborative observational studies on drug safety.

What to expect from the new leadership and why there's not much hope for an improved directive.

What antitrust authorities have uncovered so far in their search for sabotage.

Along with the titles and phone numbers of personnel, View from Brussels columnist Peter O'Donnell provides an update on the regulatory front in Europe.

Animal use in clinical trials comes into question as Europe debates an update of current rules.

The EU provides extensive funds to the clinical trials industry in an effort to better health care delivery.

Keeping score of Europe's one-year-old initiative to promote research for the pediatric community.

Slowdown in new drugs to market prompts antitrust investigation by EU competition authorities.

From a new guidance on inspections to a bid to help the EU regain its R&D prowess, the Agency is busy.

In the European Union, regulators are agonizing over more than just clinical trials.

With backing from pharma and high hopes, Eu takes steps to improve front-end approaches to R&D.

New regulations prompt the EU to request more info from sponsors on clinical trial applications.

Some of the tangible outcomes expected to emerge from a pediatric network include scientific and operational quality standards.

EMEA and EC admit to legislation difficulties, and many voice their ideas in an effort to make improvements.

Expect a raft of new or revised EU guidelines for efficacy testing of pharmaceuticals in '08.

Europe took a step toward improving the operation of its much-criticised clinical trials directive on October 3-but only a step.