December 1st – December 2nd 2022
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
[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.
● 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