2nd Annual Genotoxic Impurities Summit: Nitrosamines & Beyond 2022 - uventia

2nd Annual Genotoxic Impurities Summit: Nitrosamines & Beyond 2022

2nd Annual Genotoxic Impurities Nitrosamines & Beyond
Event Details


The formation of nitrosamines as well as other mutagenic impurities in drug substances and drug products may compromise their safety, quality, and clinical outcomes. Estimating impurity profiles, as well as controlling and monitoring them, has become an unavoidable aspect of the comprehensive development and production of novel medicines. The proactive detection of genotoxic impurities should be implemented at every step of drug development to comply with growing regulatory standards and avoid costly recalls.

We organized an online discussion with industry experts to present and discuss various perspectives on how to address the concerns of mutagenic impurities. We’ll go over drug impurity profiling strategies that follow regulatory guidelines, as well as practical tips for complying with recent updates in ICH M7 and Q3D, latest nitrosamine regulations, nitrosamine impurity identification and quantification, risk assessment of genotoxic impurities, analytical complexities and genotoxicity prediction, development of acceptance criteria, and the most recent progress in the examination of elemental impurities.

Book your spot for our webinar to learn about best practices and innovative approaches to genotoxic and other mutagenic impurities control.


  • Nitrosamine risk assessment in pharmaceuticals.
  • Nitrosamine risk assessments – a case study with focus on nitrite levels and nitrite testing.
  • Exploring the scale of potential nitrosamine risk associated with existing approved APIs.
  • Avoiding ndma formation in metformin pharmaceuticals.
  • Determination of nitrosamines in drug substances and drug products.
  • Setting limits for complex nitrosamines.
  • One year since official date of USP <1469> nitrosamine impurities.
  • Nitrosamines from elastomeric closures – risk and mitigation.
  • Pharmaceutical operations as generators of nitrosamines - prevention or cure?
  • In silico methods to determine genotoxic impuritie.
  • Incorporation of ICH M7 guidelines.
  • The use of structure-activity relationships in the risk assessment of nitrosamines.
  • Setting toxicological-based limits for nitrosamines.


CxO, VP, 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] 2nd Annual Genotoxic Impurities Summit: Nitrosamines & Beyond 2022

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

Speaking Companies

Previous Event

● 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
Edmond Biba
Principal Scientist
US Pharmacopeia (USP)
Joerg Schlingemann
Principal Expert Quality Control Systems
Merck Healthcare KGaA
Ruth Boetzel
Senior Principal Scientist
Malcolm Ross
Kevin Cross
VP, Principal Investigator U.S. FDA Research Collaborations
Instem Inc.
Teresa Wegesser
Sr. Principal Scientist
Amgen Inc.
Rok Grahek
Head Analytical Research
Susanne Glowienke
Head Impurity Safety
Novartis Pharma AG
Mike Urquhart
Scientific Director
Bettine Boltres
Principal Scientific Affairs
West Pharmaceutical Services
Raphael Nudelman
Senior Director Impurity Expert, R&D Operations
Teva Pharmaceutical Industries Ltd.
Alejandra Trejo-Martin
Sr. Associate Scientist
Gilead Sciences Inc.
Michael Burns
Principal Research Scientist
Lhasa Limited

Summit Agenda

◆  Background to impurity control, ICH M7 for mutagenic impurities and nitrosamines.

◆  Development of cross industry approaches to nitrosamine assessment of API and drug product.

◆  Experiences from Step 2 testing and discharging risk to potential Remediation activities.

◆  Positioning of regulatory submissions.


◆  Identification of at-risk amine.

◆  Assessment of formulation for presence of nitrite.

◆  Use of the Lhasa Vitic Nitrite in Excipients database.

◆  Nitrite test methods – challenges and ongoing comparative testing.

Pfizer Global R&D, UK

◆  Assessing the true scale of potential impact on pharmaceutical supply using existing drug databases.

◆  Identifying trends of nitrosamines that may theoretically form.

◆  Provide some context for ongoing activities relating to nitrosamines.

Lhasa Limited, UK

◆  Contribution from nitrite in excipients.

◆  Contribution from API impurity F (DMA).

◆  Analytical challenges.

◆  (possibly: NOx-mediated nitrosation).

Merck Healthcare KGaA, DE

◆  Analytical techniques / methods and Limit of Detection.

◆  Volatile nitrosamines in drug substances and in drug products.

◆  Nitroso drug substances in drug products.

Sandoz, SI

◆  Read-across in guidelines.

◆  Examples & challenging regulators read-across.

◆  Read-across for complex nitrosamines.

◆  Mechanistic de-risking.

Teva Pharmaceutical Industries Ltd., IL

◆  Background on nitrosamines as public health concern.

◆  Regulatory Landscape.

◆  USP perspective on addressing nitrosamines in pharmaceutical products.

◆  USP <1469> Nitrosamine Impurities content and rationale.

◆  One year of stakeholder’s feedback and questions on <1469>.

United States Pharmacopeia, USA

◆  Science of Elastomers.

◆  Science of Nitrosamines from Rubber.

◆  Addressing Nitrosamines from Pharmaceutical Elastomers.

◆  Risk Assessment of Nitrosamines from Pharmaceutical Elastomers.

West Pharmaceutical Services, DE

◆  Formation of nitrosamines does not only occur during manufacture of drug substances but can occur during manufacture of drug product.

◆  Different unit operations exhibit different levels of risk and mechanisms are still being elucidated.

◆  Prevention of formation during drug product production may be through control of processes, control of excipients or use of nitrosamine scavengers.

Generapharm, CH

◆  In silico evaluation in relation to ICH M7.

◆  Best techniques for in-silico hazard assessment.

◆  Managing contradictory outcomes.

◆  Methods for improving predictive systems.

Novartis, CH

◆  ICH M7 in Early and Late Drug Development.

◆  Impurity Qualification Using (Q)SAR Techniques.

◆  Producing (Q)SAR Assessments in Compliance with ICH M7.

Amgen Inc., USA

◆  The mechanisms for nitrosamine mutagenicity.

◆  Structural features affecting mutagenicity potency.

◆  Methods for Risk Assessment of nitrosamines.

Instem, Inc., USA

◆  Setting Toxicological-Based Limits for Mutagenic Impurities under ICH M7.

◆  Differences Between ICH and Nitrosamine Guidances.

◆  Case Examples.

Gilead Sciences Inc., USA

Event Details