Tag Archive

The following is a list of all entries tagged with repeat tested donors:

Comments (1)

Drug Development Regulations – EMEA releases draft guidline on Epidemiology Data on Blood Transmissible Infections

Filed in clinical,manufacturing,regulatory, July 27, 2009, 7:36 am , , , , , ,

In the light of experience gained with the application of the Guideline on Epidemiological data (published in Jan. 2005) a group of experts was assigned to critically look at the: 2006 epidemiological data submitted in the Plasma Master File (PMF) annual update, in conjunction with the CHMP Epidemiological guideline, 2006 and 2007 PMF evaluation reports for the relevant PMF Feedback on this work was provided to the PMF Drafting Group and to BWP/CHMP and a revision of the guideline was recommended.