3rd Annual Genotoxic Impurities Summit: Nitrosamines & Beyond 2023 - uventia

3rd Annual Genotoxic Impurities Summit: Nitrosamines & Beyond 2023

3rd Annual Genotoxic Impurities Nitrosamines & Beyond
Event Details


The safety, quality and clinical results of drug substances and drug products may be disrupted by the formation of nitrosamines along with other mutagenic impurities. The comprehensive development and production of innovative medicines now inevitably involves estimating impurity profiles as well as managing and monitoring them. To meet the demands of ever-increasing regulatory standards and avoid expensive recalls, proactive detection of genotoxic contaminants should be adopted at every stage of pharmaceutical development.

We plan an online meeting with subject-matter experts to evaluate multiple perspectives on how to handle the concerns of mutagenic impurities. We will cover regulatory-compliant drug impurity profiling practices; helpful hints for adhering to recent ICH M7 and Q3D updates; nitrosamine impurity identification and quantification; risk evaluation of genotoxic impurities; analytical challenges and genotoxicity prediction; establishment of acceptance criteria; and the most recent developments in the analysis of elemental impurities.

Save a seat at our webinar to find out about most effective methods for genotoxic and other mutagenic impurity management.


  • Revisiting the landscape of complex nitrosamines.
  • The EDQM response to nitrosamines.
  • Management of N-nitrosamines and their risk assessment within GSK R&D.
  • Setting limits for NDSRIs.
  • Using genetic toxicity data to support risk assessment of nitrosamines.
  • Nitrosamines, industry perspective.
  • Setting acceptable intakes (AIS) for complex nitrosamines.
  • Toxicological assessment of nitrosamines.
  • Nitrosamine drug substance - related impurities management at SEQENS.
  • In silico evaluations to assess mutagenicity of impurities.
  • ICH M7 approaches in peptides that are developed as NCEs.
  • Genotoxic impurities in medical devices.
  • Extractables and leachables - potential genotoxic impurities?
  • Expert analysis and in-silico QSAR methodologies to assess the mutagenicity potential of impurities.
  • Toxicological risk assessment, ISO certification, compliance, art and sciences of chemical characterization of nitrosamines. Are we doing the right thing?
  • An update on the ongoing efforts to optimize the ames assay by the hesigttc mechanism-based genotoxicity risk assessment (MGRA) nitrosamine subgroup.
  • Challenges encountered during the attempted quantification of nitrosodimethylamine (NDMA) in rubber using traditional extraction techniques.


CxO, VPs, Directors, Heads, Managers 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] 3rd Annual Genotoxic Impurities Summit: Nitrosamines & Beyond 2023

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

Speaking Companies

● A&M STABTEST GmbH ● Abbott ● ACG Europe d.o.o. ● Adamed Pharma S.A. ● Advanz Pharma ● AGES-MEA ● ALK-Abelló S.A. ● American Regent ● AMSlab ● Angelini Pharma S.p.A. ● APIs & NCE Manufacturing LeadAC Immune SA ● Aptuit an Evotec Company ● ARLANXEO Netherlands B.V ● Arrotex Pharmaceuticals Pty Ltd ● Astellas Pharma Europe BV ● Astellas Pharma Inc. ● AstraZeneca ● BD Technologies ● Boehringer Ingelheim Pharma GmbH & Co. KG ● Charles River Laboratories ● Chugai Pharmaceutical Co., Ltd. ● Croma-Pharma GmbH ● CSL Behring ● Dottikon Exclusive Synthesis AG ● EDQM, Council of Europe ● Excella GmbH & Co. KG ● FARMAK, a.s. ● Fermion Oy ● Fresenius Kabi ● Fresenius Kabi Deutschland GmbH ● FUJIFILM Toyama Chemical ● Gentronix Ltd ● Grunenthal Ecuatoriana Cia. Ltda. ● GSK ● Haleon ● Health and Environmental Sciences Institute (HESI) ● Hemofarm AD ● Hemomont d.o.o. ● Idorsia ● Insight Exposure and Risk Sciences ● Intertek ● Intertek Melbourn ● Intox Private Limited ● Intuitive Fluorescence Imaging, LLC ● Johnson&Johnson ● Konya Food and Agriculture University ● Krka d. d., Novo mesto ● L.Molteni & C. dei F.lli Alitti SpA ● LabAnalysis S.r.l. ● Laboratoires MAYOLY SPINDLER ● Labtim ADRIA d.o.o. ● LangAllan CMC Regulatory Solutions Ltd ● Lek Pharmaceuticals d.d. ● Lhasa Limited ● Lundbeck ● Luye Pharma AG ● Merck Healthcare KGaA ● Midas Pharma GmbH ● MultiCASE Inc ● National Institute of Health Sciences ● Norwich Pharmaceuticals ● Novartis ● Olon S.p.A. ● Orion Pharma ● Pfizer ● Pharmaceutical firm Darnitsa ● Polpharma ● Preclintox Services, LLC ● ProBioGen AG ● Rontis Hellas ● S-IN Soluzioni Informatiche ● Safetree Consulting e.U. ● Sanofi ● SEQENS ● Solvias AG ● State Agency of Medicines ● Swansea University ● Swissmedic ● Takeda ● Takeda Pharmaceuticals ● Tallinn University of Technology ● Teva Pharmaceutical Industries Ltd. ● TEVA Pharmaceutical Works Ltd ● Teva Pharmaceuticals ● ToxMinds BVBA ● UCB ● Vertex Pharmaceuticals ● Viatris ● Waters ● Waters Corporation ● Zakłady Farmaceutyczne Polpharma ● Zentiva Group, a.s.

● Adamed Pharma ● Lundbeck ● Astellas Pharma Europe B.V. ● Sanofi ● Dr. Reddy's Laboratories Limited ● Airnov Healthcare Packaging ● Egis Pharmaceuticals Plc. ● Waters Corporation ● Teva Pharmaceutical ● Synthon ● Synthon B.V. ● Polpharma ● Silence Therapeutics ● Menarini Ricerche ● Polpharma SA ● Krka ● Teva Pharmaceutical Industries Ltd ● Teva Active Pharmaceutical Ingredients ● Neurocrine Biosciences ● JSC Olainfarm ● Bibra toxicology advice & consulting Ltd ● Berlin-Chemie AG ● Janssen Pharmaceutica ● Jazz Pharmaceuticals ● Pliva Hrvatska d.o.o. ● Dr. Anika Schroeter e.U. ● Eurofins PSS ● Angelini Pharma S.p.A. ● Food and Drug Administration ● Astellas Pharma Europe ● Saneca Pharmaceuticals ● Teva Israel Ltd ● Arrotex Pty Ltd ● Merck Healthcare KGaA ● Boehringer Ingelheim Pharma GmbH & Co. KG ● Bracco Imaging SpA ● Perrigo ● Chiesi Farmaceutici SpA ● Advanz Pharma ● Midas Pharma GmbH ● Aptuit an Evotec Company ● Hikma Pharmaceuticals ● Aptuit (Verona) S.r.L., An Evotec Company ● Adamed Pharma S.A. ● fagg-afmps ● World Health Organization (WHO) ● Curia Spain S.A.U. ● Swissmedic ● Albhades ● Finnish Medicines Agency ● Selvita S.A. ● Fresenius Medical Care Deutschland GmbH ● Fresenius Kabi ● IFF ● Teva Ni Ltd ● Bayer AG ● FUJIFILM Toyama Chemical Co., Ltd. ● INEOS Oxide ● Affygility Solutions ● Laboratorium Zdrochem sp. z o.o. ● Zentiva, k.s. ● Janssen ● Bachem AG ● BD ● Jagiellonian Center of Innovation ● Sanofi Chimie ● Venn Life Sciences ● Merck KGaA, Darmstadt, Germany ● Teva Gyogyszergyar Zrt. ● Drug Development Solutions ● Senior Consultant ● Lonza AG ● Alliance Pharmaceuticals Ltd ● Minakem ● B. Braun Medical, S.A.U. ● Smith + Nephew ● Haleon ● LabExperts Sp. z o.o. ● Technologie Servier ● Ipca Laboratories Ltd. ● Recipharm Pharmaservices Pvt Ltd ● ANTIBIOTICE SA ● Pharmaceutical Firm Darnitsa ● Bausch Health ● Idorsia ● Pfizer ● Avivia ● Altox ● West Pharmaceutical Services ● GSK ● Novartis ● Teva Pharmaceuticals ● Lhasa Limited ● Gilead Sciences Inc. ● Amgen Inc. ● Sandoz ● Instem, Inc. ● Generapharm ● Pfizer Global R&D ● United States Pharmacopeia

● 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
Gautier Decock
Managing Director of Seqens CRDO Business
Samuel Conway
Staff Scientist II
BD Technologies
George Johnson
Associate Professor
Swansea University
Alyssa Musso
Senior Scientist, Drug Safety Research and Development
Andrew Poulton
Associate Principal Scientist, Pharmaceutical Sciences
Andreas Czich
Toxicologist, Senior Distinguished Scientist
Mourad F. Rahi
Senior Consultant Chemist
Preclintox Services, LLC
Avital Talya Milenkiy
Chemical Toxicologist
Teva Pharmaceutical Industries Ltd.
Leon F. Stankowski
Senior Scientific Director, Genetic and In Vitro Toxicology
Charles River Laboratories
Bruno Spieldenner
Head of Division
EDQM, Council of Europe
Jasmin Lott
Associate Director
Boehringer Ingelheim
Susanne Glowienke
Head Impurity Safety
Novartis Pharma AG
Mike Urquhart
Scientific Director
Patrick Reichl
Toxicology Lead
Croma-Pharma GmbH
Reinhard Stidl
Senior Toxicologist - Managing Director
Safetree Consulting e.U.
Raphael Nudelman
Senior Director Impurity Expert, R&D Operations
Teva Pharmaceutical Industries Ltd.
Michael Burns
Principal Research Scientist
Lhasa Limited

Summit Agenda

◆  Examining how the CPCA has changed the regulatory landscape for nitrosamines.

◆  Impact on drug manufacturers.

◆  Areas that require further understanding and evolution.

Lhasa Limited, UK

The presentation will start with a short overview of the EDQM and how it fits in the European regulatory system. 

The historical evolution from the outbreak of nitrosamines in June 2018 to today and the actions taken on the EU/EC/EMA regulatory level as well as at EDQM will be provided. 

Finally, the EDQM response to nitrosamines will be provided by detailing the actions undertaken and still ongoing within the three main tracks that are: the texts of the European Pharmacopoeia, the testing of batchs within the Official Medicines Control Laboratories and the Certification (CEP) procedure.

EDQM, Council of Europe, FR

◆  How N-nitrosamines might form within DS and DP and how to assess.

◆  Experiences of Step 2 testing.

◆  Steps taken when an N-nitrosamine and/or N-nitroso drug substance related impurity (NDSRI) is confirmed.

◆  How GSK are assessing risk in R&D.

◆  Reflections and looking forward.


◆  Misalignments between ICH M7 and regulatory requirements for nitrosamines.

◆  Difficulty in setting acceptable intake (AI) levels for nitrosamine drug substance related impurities (NDSRIs).

◆  Proposals for AIs of nitrosamines of classes of drugs - position papers for nitrosamines of calcium channel blockers, beta-blockers and beta-agonist, and ACE inhibitors.

◆  Use of in vivo mutagenicity data to categorize the potency of NDSRIs.

Teva Pharmaceutical Industries Ltd., IL

◆  In vivo mutation and cancer potency.

◆  Using in vivo mutation data to support potency categorisation.

◆  Next steps and upcoming data sets and approaches.

Swansea University, UK

◆  Understanding of the evolution of the issue – Valsartan to NDSRIs. 

◆  Current risks – progress against deadlines. 

◆  Areas of uncertainty and their impact.

◆  Where will we be in 12 months times.

AstraZeneca, UK

◆  Categorizing and deriving AIs for complex API-like nitrosamines.

◆  Two to three specific case studies providing examples of how AIs were derived based on experimental data.

Pfizer, USA

◆  Mutagenicity and Carcinogenicity of Nitrosamines.

◆  Mechanisms.

◆  Differences between small molecular weight Nitrosamines and NDSRI.

◆  The LTL concept.

◆  Using SAR, QM and Metabolism data to support AI.

◆  Improving the adherence to ICH M7.

Sanofi, DE

◆  Risk Assessment Approach.

◆  Analytical Screening & Identification of NDSRIs.

◆  Toxicological Qualifications.

◆  Quantification of Ultra-Traces NDSRIs.

◆  Control Strategy.

Seqens, FR

◆  QSAR approaches to detect structural alerts.

◆  Read-across approaches to assess prediction results.

◆  In vivo/in vitro genotoxicity studies assessing genotoxicity.

Novartis, CH

◆  ICH M7 has to be followed for peptides developed as NCEs.

◆  (Q)SAR predictions following ICH M7 lead to class 3 readouts in many structures.

◆  Using a „substructure“ approach might help there.

Boehringer Ingelheim Pharma GmbH & Co. KG, DE

◆  Regulatory framework for GIs in Medical Devices.

◆  Recent developments (ISO 10993-17:2023).

◆  Case studies.

Croma-Pharma GmbH, AT

◆  Different regulatory expectations on toxicological risk assessments for different classes of impurities.

◆  Potential E&L genotoxicity - impact of route of administration on Threshold of Toxicological Concern.

◆  Hazard characterization of identified and not identified extractables and leachables.

◆  Assessment of data poor substances: (Q)SARs and read-across.

Safetree Consulting e.U., AT

◆  Different methodologies applied for a comprehensive mutagenicity assessment.

◆  Case studies presenting the overall assessment of impurities associated with QSAR: equivocal predictions, inconsistent in silico predictions, unclassified, misclassified and out of domain chemical moieties.

◆  Analyzing the in vitro Ames test results, in order to provide mutagenicity assessment based on experimental data.

Teva Pharmaceutical Industries Ltd., IL

◆  Ambiguity of guidelines for drugs vs medical devices for calculation of Analytical Evaluation Threshold (AET) for toxicological risk assessment.

◆  Effect of solvent selection and concentration of extracts on impurities profiling.

◆  Chromatographic and spectroscopic skills in mass spectra interpretation for identification of Nitrosamines in screening modes.

Preclintox Services, LLC, USA

◆  The analysis of nitrosamines in drug products is well studied, but little is reported regarding the content of nitrosamines in pharmaceutical rubber.

◆  Highly inconsistent results were obtained using traditional extraction techniques to evaluate the content of nitrosodimethylamine (NDMA) in rubber.

◆  Evidence suggests that NDMA is formed in situ during (and after) extraction.

◆  NDMA may not be present in the rubber in its native form, but may be generated by attempts to detect it.

BD Technologies, USA

Event Details