Genotoxic Impurities Summit: Nitrosamines & Beyond 2021 - uventia

Genotoxic Impurities Summit: Nitrosamines & Beyond 2021

Genotoxic Impurities Summit Nitrosamines Beyond
Event Details


The presence of nitrosamines and other mutagenic impurities might adversely impact the safety, quality and efficacy of drug substances and drug products. The estimation of the impurity profiles and their control and monitoring became an inevitable part of the successful development and production of new drugs. To comply with increased regulatory requirements and avoid expensive recalls, the proactive identification of genotoxic impurities should be established at every stage of drug development.

Together with industry experts we put an online meeting to present and explore varied opinions on how to tackle the challenges of mutagenic impurities. We will review drug impurity profiling strategies in line with regulatory guidelines, practical insights for compliance with the recent updates in ICH M7 and Q3D, new nitrosamine regulations, determination and calculation of nitrosamine impurities, risk assessment of genotoxic impurities, analytical challenges and genotoxicity prediction, development of acceptance criteria, latest advances in the assessment of elemental impurities.

Save your seat for our solution-packed webinar to be equipped with best practices and novel approaches to control genotoxic and elemental impurities.


  • European pharmacopoeia activities on control of nitrosamines and other DNA-reactive impurities.
  • Continuing development of applied chemical knowledge for an in silico purge tool: learning lessons from nitrosamines.
  • Challenges in trace analysis of nitrosamines - resolving through innovation and global collaboration.
  • A quantum chemical approach to estimate the mutagenic potential of nitrosamines after metabolic activation.
  • Challenges and strategies for in-house implementation of nitrosamines analytical methods.
  • N-nitrosamines challenges – USP’s approach & resources.
  • Setting limits for nitrosamines.
  • Stop searching - start looking. A breakthrough in chromatography technologies.
  • Genotoxic impurities in medical devices.
  • In silico techniques for the evaluation of genotoxic impurities.
  • Setting safety based limits for genotoxic and non-genotoxic impurities.
  • SCIEX solutions for nitrosamine analysis (and beyond).
  • Current investigations of N-nitrosamines in the bacterial reverse mutation assay.
  • Use of bacterial reverse mutation assay as predictor of the carcinogenic potential of nitrosamines.


CxOs, VPs, Directors, Heads, Managers, Principal Scientists of

  • Genotoxic Impurities/ GTIs/ Genotoxins/ Elemental Impurities
  • Genotoxicity/ Mutagenicity
  • Carcinogenicity/ Carcinogens
  • Genetic Toxicology/ Chemical Toxicology/ Computational Toxicology
  • Analytical Chemistry/ Analytical Development/ Analytical Science
  • Drug Discovery/ Drug Development/ Drug Substance
  • Drug Safety/ Compound Safety
  • Process Chemistry/ Process Development
  • Product Characterisation/ Risk Assessment
  • Pharmacokinetics/ Metabolism
  • Extractables & Leachables
  • API Development/ Degradation Products
  • LC-MS/ Mass Spectrometry
  • Good Laboratory Practice (GLP)/ Good Manufacturing Practice (GMP)
  • Regulatory Affairs & Compliance

[Agenda] Genotoxic Impurities Summit: Nitrosamines & Beyond 2021

Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session.

Speaking Companies

● AB Sciex Pte. Ltd. ● Adamed Pharma S.A. ● Alkaloid Skopje ● Almirall S.A. ● Angelini Pharma ● AstraZeneca ● Bausch Health ● Bayer AG ● Becton Dickinson ● Bilim Pharmaceuticals ● Cambrex Profarmaco Milano sr ● Cehtra ● Chemsafe Srl ● Chiesi Farmaceutici SpA ● CPAM du Cher (Assurance Maladie) ● Croma-Pharma GmbH ● Curia Italy s.r.l. ● Dechra Pharmaceuticals Manufacturing ● Dexcel LTD ● Dottikon Exclusive Synthesis AG ● EDQM, Council of Europe ● ERBC srl ● Ever Valinject GmbH ● FUJIFILM Toyama Chemical Co., Ltd. ● Gilead Sciences Inc. ● Givaudan International SA ● GlaxoSmithKline Consumer Healthcare ● Halmed ● Health Care Solution ● Helsinn Advanced Synthesis SA ● Hemofarm AD ● Janssen ● Janssen R&D (J&J) ● JAZMP ● Johnson & Johnson ● L’Oreal ● Lek Pharmaceuticals d.d. ● LGCGroup ● Lhasa Limited ● Liverpool John Moores University ● Malta Medicines Authority ● Merck Healthcare KGaA ● Merck/Sigma Aldrich ● Moehs Iberica, SL ● Novartis ● Orion Corporation ● Pfizer HealthCare ● Pfizer LIMITED ● Polpharma ● PRO.MED.CS Praha a.s. ● QPLAB ● Rajarshi Shahu College of Pharmacy ● Ravimiamet ● Ravimiamet – State Agency of Medicines ● Reading Scientific Services Ltd ● Safetree Consulting e.U. ● Sandoz ● Sanofi ● Sanofi Aventis ● Sanofi-Aventis ● Sidefarma S.A ● SK biotek Ireland ● State Agency of Medicines of Latvia ● State Institute for Drug Control ● Takeda ● Teva api ● Teva Pharmaceutical Industries LTD ● Teva Pharmaceuticals ● Teva Pharmaceuticals Ltd-Generic ● The United State Pharmacopeia (USP) ● Thermo Fisher Scientific ● Trasis ● Waters GesmbH

Speaker Board
Rainer Rozenich
Business Development Manager (EE, CIS, ME & SSA)
Waters GesmbH
Maria João Sarmento
Head of Research & Development
QPLAB Pharma Services
Ulrich Rose
Head of Division A and Deputy Head of European Pharmacopoeia Department
EDQM, Council of Europe
Patrick Reichl
Toxicology Lead
Croma-Pharma GmbH
Tony Bristow
Principal Scientist for Measurement Science
Stephanie Simon
Head, Genetic Toxicology
Merck Healthcare KGaA
Reinhard Stidl
Senior Toxicologist - Managing Director
Safetree Consulting e.U.
Jan Wenzel
Scientist Computational and Systems Toxicology
Raphael Nudelman
Senior Director Impurity Expert, R&D Operations
Teva Pharmaceutical Industries Ltd.
Professor of Predictive Toxicology
Liverpool John Moores University
Naiffer Romero
Scientific & Compendial Affairs Sr. Manager
The United State Pharmacopeia (USP)
Alejandra Trejo-Martin
Sr. Associate Scientist
Gilead Sciences Inc.
Michael Burns
Principal Research Scientist
Lhasa Limited
Jack Steed
Technical Specialist

Summit Agenda

◆  Ph. Eur. General policy on DNA reactive impurities.

◆  Consequences for individual and general monographs.

◆  New general chapter.

◆  Latest revision of sartan monographs.

◆  Latest revision of General monographs.

EDQM, Council of Europe, FR

◆  The evolution of trace analysis of nitrosamines.

◆  Developing the scientific understanding of the sources of nitrosamine formation and the role of analytical science.

◆  Innovation within the mutiple elements of nitrosamine trace analysis science to enhance method sensitivity, capability and robustness.

AstraZeneca, UK

◆  Computational quantum chemistry approach to assess the reactivity of Nitrosamines.

◆  Introduction of metabolic activation in the calculation of reactivity.

◆  Case studies on different nitrosamines.

Sanofi, DE

◆  Development of analytical methods: challenges and regulatory requirements.

◆  Continuous adjustment of the analytical methods to cope with the evolution of the regulatory needs.

◆  Internal capability: challenges to keep up with the market/regulatory needs.

QPLAB Pharma Services, PT

◆  The nitrosamine impurities crisis prompted regulators around the world to increase their scrutiny of drug manufacturing processes even further. In the future, this greater scrutiny may lead to the discovery of nitrosamine impurities in other medicines. For this reason, manufacturers need to understand which medicines are likely to form nitrosamines, how and at what levels nitrosamine impurities are forming, and how to control nitrosamines.

◆  In the following seminar we will explore how USP responded to the nitrosamine impurities crisis with a proposed general chapter on nitrosamine impurities that provides a risk assessment strategy, methods for detecting and measuring nitrosamine impurities, along with physical reference standards against which manufacturers can compare their test results. Additionally, USP have create a whole suite of resources and tools for stakeholders to effectively face the challenges of Nitrosamine Impurities.

The United State Pharmacopeia (USP), USA

◆  Setting accptable intake levels for nitrosamines by using read-across methods.

◆  Setting limits for complex nitrosamines.

◆  Mechanistic de-risking of nitrosamines.

Teva Pharmaceuticals, IL

The evolution of stainless-steel instruments to bioinert systems and finally to our latest addition, the ACQUTIY Premier system, featuring nonmetallic surfaces in the entire flow path of the chromatographic system including the column used. Obtain a new level sensitivity and reproducibility for a plenty of compound classes, without the burdens of passivation, coatings, use of additives or use of peek material that all come along with consequences on user-experience and lab efficiency.

Waters GesmbH, AT

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◆  Regulatory framework for GIs in Medical Devices.

◆  Recent developments.

◆  Case studies.

Croma-Pharma GmbH, AT

◆  Structure-based methods from threshold of toxicological concern (TTC) to AI.

◆  Good practices in in silico genotoxicity predictions.

◆  Providing confidence in your predictions.

Liverpool John Moores University, UK

◆  General approaches for GI and NGI safety threshold derivation.

◆  Acceptable exposure calculations based on TD50 and their limitations.

◆  Route-to-route considerations for safety thresholds.

◆  Calculation of concentration limits in drug substances and drug products.

Safetree Consulting e.U., AT

◆  A comprehensive overview of N-nitrosamine analysis in multiple drug products and APIs, using both nominal mass and high resolution SCIEX instumentation.

◆  A method and summarization of AZBT analysis which in addition to N-nitrosamines has been a cause of concern in sartan medications.

◆  How the ultra high level sensitivity of the SCIEX 7500 system can help in nitrosamine analysis, with LLOQ values down to 0.01 ng/mL.


◆  Induced rat liver S9 mix can activate short chain substituted N-nitrosamines exerting their mutagenic potential independent on the chain lengths.

◆  For methyl substitution, the preincubation protocol is recommended while with increasing chain length the plate incorporation protocol is favored.

◆  The bacterial reverse mutation assay can detect the mutagenic potential of short chain alkyl nitrosamines using OECD 471 recommendations.

◆  Salmonella strains TA100 and TA1535 and E. coli WP2 uvrA are sensitive to detect the mutagenicity of N-Nitrosamines.

Merck Healthcare KGaA, DE

◆  Ntrosamines Ames/carcinogenicity concordance.

◆  Impact of expeirmental variaions in the Ames protocol.

◆  Propose Ames study design for Nitrosamines.

Gilead Sciences Inc., USA

Event Details