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Formazione >> Webinar e Formazione Online >> Free Live Webinar "Identification of Unknown Pharmaceutical Impurities"

Free Live Webinar "Identification of Unknown Pharmaceutical Impurities"

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DATA: 16 novembre, 2021 | 3.00 PM - 4.00 PM CET 

FREE WEBINAR: La partecipazione è gratuita previa conferma da parte degli organizzatori dell'evento

LINGUA: Italiano

MODALITA': Live Online Training | Piattaforma Go To Webinar

CAPIENZA PIATTAFORMA: 100 utenti. Per agevolare la partecipazione di tutte le aziende interessate saranno consentiti massimo due partecipanti per azienda. In caso di raggiungimento del numero massimo di accessi alla piattaforma sarete contattati via mail.

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La partecipazione è gratuita previa conferma da parte degli organizzatori dell'evento. Riceverete una mail di conferma dal sistema con tutti i dettagli relativi alla partecipazione. 

Download Brochure Identification of Unknown Impurities (PDF)

Introduzione

Impurity profiling is mandatory in the manufacturing process of pharmaceutical products. The presence of impurities could affect the quality and safety of drug products posing health risks to patients due to their potentially carcinogenic or immunogenic effects. The large number and variety of potential impurities presents a significant analytical challenge for their detection, quantification, and characterization. One pertinent threat is that some potential impurities will be unknown. The identification of such impurities represents a critical analytical step in the drug development process, aiming to elucidate chemical structures of unidentified species, present above a certain significant threshold. 

The capacity of identifying the molecular formula and the chemical structure of an impurity may help in understanding its formation mechanism, resulting in a broad spectrum of possibilities: determine toxicological issues, improve process purification steps, optimize synthetic pathways and select new suitable packaging.

Thanks to our solid expertise in the field, our leading experts will discuss the most relevant aspects of the regulatory framework providing also valuable insights on the analytical and toxicological requirements to identify unkwnown impurities. Up-to-date case studies will be showcased to help clients understand how to overcome the threat of unknown impurities and quantify them with high accuracy and sensitivity.

Webinar Agenda
  • Unknown impurities in pharmaceutical products: Regulatory framework
  • Impurity characterization: From an unknown peak to an identified chemical structure
  • Safety qualification: In silico  derivation of Permitted daily exposure and margin of safety calculation
  • Case studies
  • Q&A session
Expert Speaker

Benedetta Riva
Benedetta graduated in Chemistry and completed a PhD in Chemical Science in Milan. She joined Eurofins BioPharma Product Testing Italy in 2017 as analyst, with the responsibility of setting up and validating analytical method for pharmaceutical products. She currently works as project leader, with major focus on elemental impurities determination and unknown impurities characterization.

Eleonora Lostaglio
Eleonora graduated in Toxicology and Safety Assessment in Milan joined Eurofins BioPharma Product Testing Italy in 2020 after experiences in In silico Toxicology Research and in the Pharmaceutical industry coverig the role of Quality Assurance. She currently works as toxicologist in the consultancy team with major focus on the Pharmaceutical area.

Moderator - Vincenzo Freli
Sales Manager Eurofins BioPharma Product Testing Italy.