September 2021 The ZyCoV-D vaccine heralds a wave of DNA vaccines for various diseases that are undergoing clinical trials around the world. India has approved a new COVID vaccine that uses circular strands of DNA to prime the immune system against the virus SARS-CoV-2. Researchers have welcomed news of the first DNA vaccine for people […]
07
Sep
Sep
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 […]
Past Events
Brexit in Pillole. Conoscere le regole per difendere i prodotti chimici nel mercato oltre Manica: aspetti regolatori e risvolti legali. Focus sull’impatto della Brexit sui Dispositivi Medici
07
Sep
Sep
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 […]
25
Dec
Dec
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 […]
25
Dec
Dec
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 […]
Newsletter
Food toxicity: hazard versus risk – Short Communication in Archives of Clinical Toxicology
05
Oct
Oct
Until recently, eating food has usually been regarded as a low-risk activity. In the last century, industrialization has changed methods and chemicals used in the food supply chain to improve production, maintenance, and acceptance by consumers. Hazardous substances can be used in these processes. However, despite the many potential health risks associated with food, in […]
Newsletter
ICH Q3D: Toxicological Assessment and PDE determination for Elemental Impurities in Topical Drugs
31
Aug
Aug
Elemental impurities (EI) in drug products may arise from several sources. They can be intentionally added or contaminants. EIs do not provide any therapeutic benefit to the patient, therefore, their levels should be controlled within acceptable limits in the drug product (DP). The ICH guideline Q3D(R1) on elemental impurities provides an appropriate process to assess […]
25
Aug
Aug
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 […]
11
Aug
Aug
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 […]
11
Aug
Aug
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 […]
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