4th Annual Genotoxic Impurities Summit: Nitrosamines & Beyond 2024 - uventia

4th Annual Genotoxic Impurities Summit: Nitrosamines & Beyond 2024

Event Details

CONFERENCE OVERVIEW

Impurities may have a negative effect on the efficacy, safety, and quality of pharmaceutical components and products. The successful development and manufacturing of novel medications now depend heavily on the assessment of the impurity profiles as well as the management and monitoring of those. The diligent identification of nitrosamines and other genotoxic contaminants should be established at every step of drug development in order to comply with growing regulatory requirements and prevent costly recalls.

Our online meeting, which we organized in collaboration with industry professionals, aimed to showcase and discuss different perspectives on addressing the challenges caused by mutagenic impurities. We will go over drug impurity profiling techniques that follow regulatory guidelines, as well as useful tips for adhering to recent updates to ICH M7 and Q3D, new nitrosamine regulations, nitrosamine impurities determination and calculation, risk assessment for genotoxic impurities, analytical challenges, development of acceptance criteria and most recent developments in elemental impurity assessment.

Reserve your spot for this informative webinar so that you can leave with new ideas and best practices for managing genotoxic and elemental impurities.

WE WILL BE FOCUSING ON

  • nitrosamine impurity risk assessment to reduce costs and accelerate timelines
  • minimizing nitrosamine contamination - from raw materials to finished products
  • appropriate analytical tools for nitrosamine impurity detection
  • practical and compliant application of ICH M7 and ICH Q3D guidance
  • impurity profiling of pharmaceutical ingredients, intermediates and finished products
  • E&L as an impurity source - mitigating the risk that comes 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

[Agenda] 4th Annual Genotoxic Impurities Summit: Nitrosamines & Beyond 2024

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

Speaker Board
Crystal DSilva
Senior Manager – Preclinical Toxicology
Baxter
Marko Trampuz
Senior Scientist
Lek Pharmaceuticals d.d.
Susanne Glowienke
Head Impurity Safety
Novartis Pharma AG
Mike Urquhart
Scientific Director
GSK
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

◆  Guidance on nitrosamine control from FDA, EMA and WHO.

◆  Impurities of nitrosamine in European Pharmacopoeia.

◆  Recommendations for regulatory submissions.

◆  Up-versioning the EFPIA DP N-nitrosamine workflow – key changes to be aware of.

◆  Importance of metabolism ID studies to reinforce output from an enhanced Ames test (EAT).

◆  Company Case study(ies) – difficulties in agreeing control limits for NDSRIs with regulators despite the advent of the CPCA approach for assigning acceptable intakes.

GSK, UK

◆  Overview of toxicological risk assessment of nitrosamines.

◆  Comparison between agency- and literature-published acceptable intake values.

◆  Challenges with the current state of affairs and future perspectives.

◆  Drug substance and drug product sample preparation.

◆  Sample preparation for poor soluble/insoluble nitrosamines.

◆  Calibration procedures for extraction efficiency.

◆  Addition of nitrite scavengers to various dosage forms inhibits N-nitrosamine formation during manufacture and storage.

◆  Nitrite scavenging activity does not directly translate to N-nitrosation inhibitory efficiency.

◆  Need for careful selection of a suitable nitrite scavenger based on the properties of vulnerable amine and dosage form.

◆  ICH M7 in early and late drug development.

◆  Producing (Q)SAR assessments in compliance with ICH M7.

◆  Impurity qualification using (Q)SAR techniques.

◆  A risk-based approach to prevent unneeded testing.

◆  Analytical advances in pharmaceutical impurity profiling.

◆  Profiling in drug substances, intermediates and drug products.

◆  In silico evaluation in relation to ICH M7.

◆  Best techniques for in-silico hazard assessment.

◆  Managing contradictory outcomes.

◆  Methods for improving predictive systems.

◆  Implementation advice for ICH Q3D.

◆  Elemental impurity control techniques.

◆  Analytical methods to assess elemental impurities.

◆  EIs in supply chain and final dosage forms.

◆  E&L and genotoxic impurities: similarities and differences.

◆  E&L and ICH M7 perspectives in defining limits.

◆  Eliminating the risks associated with E&L.

◆  Calculating exposure limits for individual compounds.

◆  Analytical methods and acceptance criteria for control and elimination of GIs.

◆  Determination of unpredicted and chiral impurities.

◆  Less-than-lifetime (LTL) limits for nitrosamines.

◆  Analysis of mutagenicity and carcinogenicity data.

◆  Estimates for the carcinogenicity of nitrosamines.

Event Details