2nd Genotoxic Impurities in Pharmaceuticals Virtual Summit 2021

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 2019 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:

• Regulatory guidelines on genotoxic impurities and strategies.
• Regulatory updates for the control and analysis of GTIs.
• Practical implementation of ICH M7 and ICH Q3D. Regulatory submission guidance.
• ICH M7(R1) and (R2) additions and compliance.
• ICH guidelines and extractables & leachables.
• Genotoxic risk evaluation - preclinical perspective:
• Genotoxic risk evaluation. In Vitro genotoxicity testing for alerting GTIs qualification.
• Genotoxic risk evaluation. In Vivo genotoxicity testing for alerting GTIs qualification.
• DNA binding assays for alerting GTIs qualification.
• Evaluating GTIs potential through structure activity relationship.
• Compound risks assessment for GTIs.
• Genotoxic metabolites identification and risk management.
• Genotoxic thresholds identification.
• Perspective GTIs risks identifications.
• GTIs risks evaluation.
• Strategies for GTIs analysis.
• Identifying API degradants potential for genotoxicity.
• Genotoxicity and carcinogenicity alerts.
• Acceptable exposure limits for impurities and compounds from carcinogenic perspective.
• Evaluation of genotoxic impurities through In silico assessment.
• In silico prediction systems.
• In silico assessment. Risks reduction through use of predictive tools.
• Preclinical assessment of GTIs. Regulatory updates, assays, data interpretation.
• Compounds purification for early toxicology profiling.
• GTIs analysis through gas chromatography.
• GTIs quantification in APIs.
• Analytical testing and control approaches for GTIs in drug substance.
• Genotoxic degradation products identification and control.
• Compound specific risk assessment - acceptable levels identification.
• Calculating compound specific exposure limits.
• Potential impurities identification - safety assessment from EL.
• GTIs risk assessment through genotoxicity screening assay.
• GTI testing at all stages of drug development.
• Genotoxic risk assessments and the purge factor methodology.
• Big Data use to improve GTIs predictions: computational methods for a better mutagenicity.
• Analytical methods and techniques to monitor potential GTIs.
• Analytical control for genotoxic impurities.
• Implementing QbD approach into genotoxic impurities control.
• Purge tools application to improve mutagen control strategies.