Mike Urquhart
Scientific Director
Mike Urquhart having originally trained as a chemist, I have over 25 years’ experience within the Pharmaceutical industry, working mainly in process development as a synthetic chemist. Roles within GSK included lab chemist, chemistry project leader for projects spanning early through to late clinical phases, team manager, Chemistry Manufacturing and Control (CMC) project manager and coordination of CMC related due diligence activities. I am a GSK mutagenic impurity risk assessment subject matter expert and co-chair the Impurities Oversight Panel. As a Senior Fellow at GSK, I work across industry within trade associations around aspects of ICH M7 and presents externally on best practice for mutagenic impurity control strategies for pharmaceutical products.
DAY 1: NOVEMBER 30th, 2023
SESSION: Management of N-nitrosamines and their risk assessment within GSK R&D
◆ How N-nitrosamines might form within DS and DP and how to assess.
◆ Experiences of Step 2 testing.
◆ Steps taken when an N-nitrosamine and/or N-nitroso drug substance related impurity (NDSRI) is confirmed.
◆ How GSK are assessing risk in R&D.
◆ Reflections and looking forward.
DAY 1: DECEMBER 1st, 2022
SESSION: Nitrosamine risk assessment in pharmaceuticals
◆ Background to impurity control, ICH M7 for mutagenic impurities and nitrosamines.
◆ Development of cross industry approaches to nitrosamine assessment of API and drug product.
◆ Experiences from Step 2 testing and discharging risk to potential Remediation activities.
◆ Positioning of regulatory submissions.
