EMA revising pediatric wavier forms

Many companies are hesitant to perform clinical studies on children due to the risks and ethical issues that can arise. This is why the European Medicines Agency (EMA) is looking into revising and reforming the product class waivers to allow companies to test new...

New report done by EMA finds deficiencies in GCP’s

A recent report done by the European Medicines Agency (EMA) on good clinical procedures (GCP) found there were deficiencies around standard operation practices (SOPs). These deficiencies were found in monitoring, data management, and other documents for trials done in...

EMA wants stakeholders’ opinions for clinical trials database

Recently, the European Medicines Agency (EMA) sent out a survey to its stakeholders asking for their opinion regarding a new clinical trials database design. The rationale for EMA asking its stakeholders for their opinions is due to new regulations that were created...

EFPIA announces position against EMA draft policy

Pharmalive.com’s Ed Silverman reports that in another attempt to stop the European Medicines Agency (EMA) from continuing with their new policy for trial data disclosure, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has openly...