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.
WE WILL TALK ABOUT
- 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
WHO IS IT FOR?
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
WHO ATTENDED THE EVENT
● 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