Qepler | summits & conferences | 2nd Annual Genotoxic Impurities in Pharmaceuticals Online Conference, 15-16 July 2021
Event Location:
Online Conference
ZOOM Events
15 - 16 July 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 2021 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 Updates on Nitrosamine Impurities.
  • Meeting the challenge of trace analysis of N-nitrosamines -The impact for the pharmaceutical industry.
  • Risk Assessment of Nitrosamines in Pharmaceuticals: Not All Nitrosamines are Highly Potent.
  • 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.
  • Setting limits for nitrosamines that lack carcinogenicity data.
  • Analytical Solutions for the Detection and Quantification of Nitrosamines Using Separations and Mass Spectrometry.
  • 3 general suggestions for assessing positive response.
  • Continuing development of applied chemical knowledge for an in silico purge tool - Incorporating lessons from nitrosamines.
  • Assessment of potential mutagenic degradation products.
  • From in silico to in vivo assessment for mutagenicity of impurities.
  • A Journey for Risk Mitigation of Genotoxic Impurities in Pharmaceutical Products.
  • Handling mutagenic extractable and leachable compounds released from devices.
  • Can the Ames test adequately predict the carcinogenic potential of nitrosamines?

Meet our Speakers

Our Sponsors

Intertek White Papers:


Abbott, NL - Amgen, USA - Angelini Pharma Spa, IT - Apotex Research Pvt Ltd, IN - AstraZeneca, UK - Bayer AG, DE - Bibra toxicology advice & consulting Ltd, UK - Boehringer Ingelheim Pharmaceuticals, Inc., USA - Bristol-Myers Squibb, USA - Charles River Laboratories Montreal ULC, CA - Charles River Laboratories, USA - Corteva, USA - CP Pharmaceuticals Ltd, UK - Egis Pharmaceuticals Plc., HU - European Environmental Mutagenesis and Genomics Society, UK - Exponent International Ltd, UK - Freyr Global Regulatory Solutions and Services, IN - FUJIFILM Corporation, JP - Gilead Sciences, USA - GlaxoSmithKline, UK - Hemogfarm AD, RS - Innovature Srl, IT - Intertek (Schweiz) AG, CH - King & Spalding, USA - Kirkland Consulting, UK - Lek d.d., SI - LEO Pharma, IE - Lhasa Limited, UK - Litron Laboratories, USA - Medichem Manufacturing (MALTA) Ltd., MT - Merck & Co., Inc., USA - Novartis GDD/CHAD, CH - Novartis, CH - Pall Corporation, USA - Pfizer Global Research and Development, USA - Pfizer, USA - Polpharma, PL - ProtoQSAR SL, ES - QACS, LTD., GR - Rentschler Biopharma SE, DE - Risk Science Consortium, LLC, USA - SafeBridge Regulatory & Life Sciences, CA - SafeBridge Regulatory and Life Sciences Group, USA - SE Tylose GmbH & Co. KG, DE - St. George's University, UK - Surface Measurement Systems Ltd., DE - Teva Pharmaceutical Industries Ltd., IL - Tofwerk, CH - ToxHub Srl, IT - ToxMinds BVBA, BE - UCB Biopharma SRL, BE - UCB Biopharma, BE - VERFORA, CH - Vertex Pharm, USA - Vertex, USA - VYNE, IL - Waters Corporation, USA - World Health Organization (WHO), CH - Yuria-Pharm LLC, UA - and others.



Abbott Healthcare Products B.V. - Alkaloid AD - Angelini - Astellas Pharma Europe BV - AstraZeneca - Bayer AG - Bristol-Myers Squibb - Charles River Laboratories - Cipla Limited - Elanco Animal Health - Elpen Pharmaceutical Co.Inc. - Eurofarma labs - F. Hoffmann-La Roche Ltd - Fresenius Kabi Deutschland GmbH - GlaxoSmithKline - Intertek (Schweiz) AG - Lhasa Limited - Merck & Co., Inc. - Nelson Labs Europe - S-IN Soluzioni Informatiche Srl - SCIEX - Smithers Rapra Ltd. - Teva - Teva Pharmaceutical Industries Ltd. - ToxMinds BVBA - UCB Biopharma sprl. - Others