Qepler | summits & conferences | 2nd Annual Genotoxic Impurities in Pharmaceuticals Online Conference, 15-16 July 2021
Event Location:
Online Conference
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:

  • 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 in genetic tox.
  • Assessment of potential mutagenic degradation products.
  • Handling mutagenic extractable and leachable compounds released from devices.

Meet our Speakers

Our Sponsors



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