Tag Archives: European Medicines Agency
By Pharm Exec | Published: June 13, 2014
The European Medicine Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines.
By Guest Blogger | Published: May 20, 2014
By Peter O’Donnell, Applied Clinical Trials. The European Medicines Agency thought it might at last be back on the road to salvation when Guido Rasi swept into town in 2011 and started ordering greater transparency in the agency’s operations. He was determined to seek a new type of trust with the agency’s various publics—and particularly […]
By Guest Blogger | Published: April 28, 2014
New data maintenance guidelines have sparked a flurry of activity in Europe. Organizations are still grappling with electronic submissions, and the need to update data is intensifying the pressure. But there is an upside, says Miranda Pothiawala. Earlier this year formal guidelines on how to maintain and update data submitted to the extended EudraVigilance Medicinal […]
By Guest Blogger | Published: April 14, 2014
By Peter O’ Donnell. The European Medicines Agency is determined to minimize opposition to its next moves on releasing clinical trial data. It announced last week yet another consultation on its plans to publish the results of trials — a policy it initially aimed at introducing from the beginning of this year. The latest twist […]
By Pharm Exec | Published: April 3, 2014
The European Parliament yesterday voted towards the adoption of the new Clinical Trials Regulation, which removes the legal framework for pharma to not publish its data by stating that information from trial study reports should not be considered commercially confidential.