In a recent article on Outsourcing Pharma, Dan Stanton discusses the new EU clinical trial regulation and it’s intention to simplify the approval process in hopes of making the EU more accessible and desirable for clinical research. The new regulation will take action...
Raps.org journalist, Alexander Gaffney reported that an EU court has surprisingly issued an interim order that the European Medicines Agency (EMA) should stop publishing any more information or documents until a final order has been passed regarding public...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?
