3rd Annual Genotoxic Impurities in Pharmaceuticals Virtual Summit 2023

Conference Overview

For the transformation of starting material into the product is needed API synthesis, which involves multiple reaction steps, including reagents, intermediates, catalysts, solvents and others. As a result, low levels of by-products may appear in API as impurities. This impurity may have toxicity, incl. carcinogenicity and genotoxicity, what may cause mutations, potentially leading to cancer. Due to this fact and focusing on ensuring safety of public health is critical to identify, monitor, analyse and control genotoxic impurities and strive to their minimum level. This has led to the crucial need in the development and improvement of analytical methods.

The Genotoxic Impurities in Pharmaceuticals Summit 2022 is focusing on overcoming challenges and barriers, sharing knowledge, strategies, best techniques and new methodologies in GTI predictions, analysis and control during the drug development process, overview and practical implementation of GTI guidelines and regulations (ICH M7 and ICH Q3D), risk assessment, exposure limits calculation and predictions' empowerment through in silico.

The featured talks on:

• Development of a drug product workflow for nitrosamine risk assessments.
• Quantitative analysis of in vivo mutagenicity dose-response data for risk assessment and regulatory decision-making: a case study of alkylnitrosamines.
• Exploring the scale of potential nitrosamine risk associated with existing approved APIs.
• Development of in silico systems for expert review under ICH M7 guideline: increasing efficiency through automated arguments.