Jim Harvey

Non-Clinical Safety (Target and Systems Safety) at GlaxoSmithKline, UK

Speaker

Global Director of the Target Systems Safety group. in the Non Clinical Safety organisation at GSK A UK registered toxicologist with extensive knowledge of the R&D process and experience in determining the potential safety liabilities of new targets and molecules in the early discovery and late stages of development respectively. Background in the use of in silico modelling platforms that supported the development of a global strategy within GSK (that involved the co-ordination of both the safety and chemistry organisations) to meet the expectations of the ICH M7 mutagenic impurities regulatory guideline, the ICH Q3A, B & C non mutagenic impurity guidelines and more recently the EMA & FDA N-Nitrosamine impurity guidelines. Non Clinical Safety Project Team representative with experience of supporting multiple phases of development including a successful NDA and ADCOM that contributed to the approval the anti-malarial drug Tafenoquine.