Category Archives: Past Events

2021 Qepler Genotoxic Impurities in Pharmaceuticals. Virtual Summit 2021 ICH M7 guideline on assessment and control of mutagenic impurities in pharmaceuticals provides a practical framework that is applicable to the identification, categorization, qualification, and control of these mutagenic impurities to limit potential carcinogenic risk. The integrated genotoxicity assessment encompasses 4 main phases from the literature […]

  Webinar AssICC – 14 Aprile 2021 Topic of the webinar was the Post-Brexit situation and how to place medical devices on the UK market. Since leaving the European Union, Great Britain has introduced some changes concerning the placing of medical devices on the UK market. On 01 September 2020, the Medicines and Healthcare products Regulatory […]

  Annual teaching event for Dr. Landolfi to Level II Master organized by the University of Bari – Pharmacy University, online thisyear for the Covid-19 pandemic.Annual teaching event for Dr. Landolfi to Level II Master organized by the University of Bari – Pharmacy University, online this year for the Covid-19 pandemic. Cosmetics in the EU […]

Presented by Dr Landolfi to the online event: Impurity Profiling Live Virtual Conference held on November 26-27, 2020, and organized by CPhl Conferences Topics of her presentation were: Understanding and analyzing guideline and its scope Guideline philosophy and intent Advancements in the guidance – New Appendix Case study Q3D guidance is a quality guideline focused […]

ICH M7 guideline: beyond synthesis and process-related impurities in pharmaceuticals; applications and perspectives Presented by Dr Landolfi to the online event: 4th Annual Impurities Summit: Genotoxic and Beyond Summit held on September 15-16, 2020, and organized by Vonlanthen. Topics of her presentation are: Extractables & Leachables: M7 approaches in defining limits Cross-contamination: how to deal […]

PDE DERIVATION FOR CLEANING PROCEDURES ToxHub and our trusted partner Innovatune organize a series of live webinars (free of charge) on: “Chemical and Toxicological Risk Assessment: how to deal with data-poor substances“. Our experts will share their insights on Toxicological Risk Assessment and in silico methods when dealing with chemicals with limited experimental data available […]

OCCUPATIONAL SAFETY ToxHub and our trusted partner Innovatune organize a series of live webinars (free of charge) on: “Chemical and Toxicological Risk Assessment: how to deal with data-poor substances“. Our experts will share their insights on Toxicological Risk Assessment and in silico methods when dealing with chemicals with limited experimental data available and in different […]

Our Toxicology Expert and CEO, Carla Landolfi, has been invited to give a talk on ICM M7 guideline: beyond synthesis and process-related impurities in pharmaceuticals; application and perspective to the webinar on Genotoxic and Elemental Impurities organized by Volanthen Group. Usually, when we talk about M7 we are talking about a process related substance or […]