| 简介/内容概述： | Establishment of an Implementation Working Group (IWG) to prepare and deliver a training programme (with associated materials) in order to facilitate an aligned interpretation and a harmonized implementation of ICH Q5A(R2) in ICH and non-ICH regions. The intent of this IWG is not to provide comprehensive training on all parts of viral safety including viral clearance evaluation and characterisation and testing, but to focus on new elements included in the revision. Technical details regarding validation of Next Generation Sequencing (NGS) will not be included in this program, however elements of this technology will be included within the training programme. |
