Genotoxic Impurities Summit: Nitrosamines & Beyond 2021 - uventia

Genotoxic Impurities Summit: Nitrosamines & Beyond 2021

December 2nd  December 3rd 2021



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.


  • risk assessment of nitrosamine impurities to optimize timelines and costs
  • mitigating nitrosamine contamination from raw material to final drug product
  • suitable analytical instruments for the detection of nitrosamine impurities
  • practical and compliant implementation of ICH M7 and ICH Q3D guidance
  • profiling of impurities in drug substances, intermediates and drug products
  • E&L as a source of impurities, eliminating the risks associated with E&L


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
Our Sponsors
Speaking Companies
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

[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.

● 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

Event Details