2nd Annual Genotoxic Impurities Summit: Nitrosamines & Beyond 2022

December 1st  December 2nd 2022

VIRTUAL CONFERENCE

CONFERENCE OVERVIEW

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.

WE WILL TALK ABOUT

  • nitrosamine impurity risk assessment to optimize timeframes and costs
  • reducing nitrosamine contamination from raw materials to finished drugs
  • appropriate analytical instruments for detecting nitrosamine impurities
  • practical and compliant implementation of ICH M7 and ICH Q3D guidance
  • impurity profiling in drug substances, intermediates, and drug products
  • E&L as an impurity source – removing the risks associated with E&L

WHO IS IT FOR?

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

WHO ATTENDED THE EVENT 2021

✴ 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

Speaking Companies
Speaker Board
Principal Scientist
USP
Principal Expert Quality Control Systems
MERCK HEALTHCARE KGaA
Senior Principal Scientist
PFIZER
Consultant
GENERAPHARM
VP, Principal Investigator U.S. FDA Research Collaborations
INSTEM
Sr. Principal Scientist
AMGEN
Head Analytical Research
SANDOZ
Head Impurity Safety
NOVARTIS
Scientific Director
GSK
Principal Scientific Affairs
WEST PHARMACEUTICAL SERVICES
Senior Director Impurity Expert, R&D Operations
TEVA PHARMACEUTICALS
Sr. Associate Scientist
GILEAD SCIENCES Inc.
Principal Research Scientist
LHASA LIMITED
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