8:30AM EST // 1:30PM BST // 2:30PM CEST
Strategic risk-based approaches for cost-effective elimination of genotoxic impurities
Identify Nitrosamine Impurity Sources. Offset Analytical Burden. Ensure Product Quality and Safety.
Discover how industry leaders are tackling genotoxic impurities
Regulatory Considerations for Genotoxic Impurities
- What are regulators expecting from analytical vs. predictive analysis for successful drug approval?
- How pharmaceutical manufacturers have dealt with the presence of impurities in APIs and altered their processes.
- With guidance on how to approach Extractables and Leachables; the importance of risk management and how current guidance can be used in anticipation of the release of ICH Q3E.
Tackling Impurities from Early to Late-Stage Development
- Streamlining processes when dealing with impurities - with discussions lead by industry experts from Pfizer, Bristol Meyers Squibb and GlaxoSmithKline.
- Hear about life cycle approaches and working to anticipate questions of safety. With talks focusing on Risk Assessment, CMC, and GMP.
- How predictive and computational methods can be used to reduce analytical burdens and improve the efficiency of manufacturing.
Dealing with N-Nitrosamine Formation in Pharmaceuticals
- Hear from leaders at Merck and Lhasa about de-risking synthesis of drug products to reduce the chance for the formation of genotoxic Nitrosamines.
- Overcoming the issue of eliminating or reducing the levels of impurities in drug products.
- Up-to-date approaches for Nitrosamine impurity detection, quantification, and removal, including analytical challenges and solutions.
Meet the Industry Leaders who are tackling the ongoing issue of genotoxic impurities
Who should attend?
You will be able to find senior multinational industry leaders working in the following fields:
Non-Clinical Drug Safety and Toxicology/Genotoxicity
Mutagenic (Nitrosamine) Impurities
Extractables & Leachables
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