Mike Urquhart
Scientific Director
Mike Urquhart (Ph.D.) works for GSK and has over 25 years’ experience within the Pharmaceutical industry, working mainly in research and development as a Synthetic Organic Chemist. Mike is a Scientific Director, having mutagenic impurity risk assessment expertise, who co-chairs both the Genotoxic Impurity Risk assessment and Impurities Oversight Panels at GSK. Mike works 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: December 4th, 2024
SESSION: Emerging focus for drug product assessment for N-nitrosamines – perspective on quality, safety and regulatory environment
◆ Emergence of new guidance to establish AI and further understanding for NDSRI formation in DP published.
◆ Changes to the DP risk assessment process as a consequence.
◆ Actions to take when an NDSRI is realised – includes discussion of using metabolism ID studies to help build understanding (weight of evidence) for the N-nitrosamine toxicity.
◆ High level overview of GSK experiences of remediation in DS and DP.
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.
