Genotoxic Impurities in Pharmaceuticals Summit in 2024 in Prague, Czech Republic

The annual Genotoxic Impurities in Pharmaceuticals Summit will be held in Prague.

To convert a starting material into a product, API synthesis is required, which involves several reaction steps including reagents, intermediates, catalysts, solvents, and others. As a result, low levels of by-products may appear in the API as impurities. This impurity may have toxicity, incl. carcinogenicity and genotoxicity, which can cause mutations potentially leading to cancer. In this regard, special attention is given to ensuring public health safety to identify, monitor, analyze and control genotoxic impurities and achieve their minimum levels. This has led to an urgent need to develop and improve analytical methods.

The 2019 Pharmaceutical Genotoxic Impurities Summit focuses on overcoming challenges and barriers, sharing knowledge, strategies, best practices and new methodologies in GTI prediction, analysis and monitoring during drug development, review and practical implementation of GTI guidelines and regulations (ICH M7 and ICH Q3D), risk assessment, calculation of exposure limits and enhanced in silico prediction capabilities.

Conference topics:

• Regulatory guidance on genotoxic impurities and strategies.
• Regulatory updates for control and analysis of GTI.
• Practical implementation of ICH M7 and ICH Q3D. Normative management presentation.
• ICH M7 (R1) and (R2) additions and conformances.
• ICH Guidelines and Recoverable and Leachable.
• Genotoxic risk assessment – preclinical perspective:
• Genotoxic risk assessment. In vitro genotoxicity testing to inform GTI qualification.
• Genotoxic risk assessment. At Vivo, genotoxicity testing informs GTI qualification.
• DNA binding assays for reporting GTI qualifications.
• Assessing the potential of GTI through the structure of activity relations.
• Assessment of complex risks for GTI.
• Identification of genotoxic metabolites and risk management.
• Genotoxic identification thresholds.
• Prospective identification of GTI risks.
• GTI risk assessment.
• GTI analysis strategies.
• Identification of API degradation potential for genotoxicity.
• Genotoxicity and carcinogenicity alerts.
• Acceptable exposure limits for impurities and compounds in terms of carcinogenicity.
• Assessment of genotoxic contaminants through in silico assessment.
• In silicon prediction systems.
• In silico evaluation. Reduce risks through the use of forecasting tools.
• Preclinical assessment of GTI. Regulatory updates, analyses, data interpretation.
• Purification of compounds for early toxicological profiling.
• GTI analysis by gas chromatography.
• Quantitative assessment of GTI in API.
• Analytical testing and approaches to control GTIs in drug substances.
• Identification and control of genotoxic breakdown products.
• Assessment of the specific risk of a compound – determination of acceptable levels.
• Calculate exposure limits for a specific compound.
• Identification of potential impurities – safety assessment from EL.
• Assessing the risk of TTI using a genotoxicity screening assay.
• GTI testing at all stages of drug development.
• Genotoxic risk assessment and purification methodology.
• Using big data to improve GTI predictions: Computational methods for better mutagenicity.
• Analytical methods and techniques for monitoring potential GTIs.
• Analytical control for genotoxic impurities.
• Implementation of the QbD approach to the control of genotoxic contaminants.
• Application of purge tools to improve mutagen control strategies.

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