EMA Offers Draft Guideline on Trial Master Files
By Zachary Brennan -
Published 13 April 2017
The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline to assist sponsors and investigators looking to comply with the requirements of the clinical trial master file (TMF), which includes documentation to allow monitoring by the sponsor and member state inspections.
Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs
Tags: trial master file, EMA guideline