Genotoxic Impurities in Drug Development
  • CODE : STEF-0025
  • Duration : 60 Minutes
  • Level : Beginner
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Dr. Stefano Persiani is currently Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy. He graduated in Pharmacy at the University of Milan, Italy and completed a Post-Doctoral fellowship in the Department of Pathology of the University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA, and later as a Research Associate in the Department of Pharmaceutics of the University of Southern California, School of Pharmacy in Los Angeles, California, USA. After these academic positions, he entered the pharmaceutical industry at Farmitalia Carlo Erba, Pharmacia, Upjohn, and Zambon Group and in the CRO sector as Scientific Director for Clinical Pharmacology. Dr. Persiani in his current role applies translational approaches from drug discovery to development and registration in several therapeutic areas. Dr. Persiani is a member of various international scientific societies and serves on the review board of numerous professional journals. Dr. Persiani acts as an external expert evaluator for the European Commission on the 7th Framework Program, Maria Sklodowska-Curie Individual Fellowships, HORIZON 2020, and Innovative Medicine Initiative. Dr. Persiani is also an expert evaluator for La Caixa Foundation where he evaluates and provides recommendations to the bank on applications requesting funding. Dr. Persiani is a faculty of Pharmaceutical Training International and Traininng.com where he provides training to pharmaceutical executives in several fields of Translational Sciences.



Residual impurities resulting from the synthetic route, the formulation, or from the degradation of the active drug and/or the excipients, may be present in the pharmaceutical products that will be administered to patients. Some of these impurities may present a potential for genotoxicity and therefore pose an additional safety concern to clinical subjects and patients. When genotoxic impurities are detected, these should be controlled and limited, if not avoided, in the final product to ensure the safety of the patients. During drug development, the strategies to control all impurities at safe concentrations are mandatory and regulated by ICH guidelines that are adopted worldwide. However, the effort made to limit impurities must be commensurate with the risk assessed at each phase of clinical development and thereafter for marketing. The webinar provides a general overview of the topic of genotoxic impurities and the approaches to safety evaluations.

Areas Covered

  • Understanding the difference between genotoxicity and mutagenicity
  • Recognize the importance of genotoxic impurities evaluations in drug development
  • Learn the necessary steps to assess the toxicological profiles of impurities
  • Learn the concept of the toxicological threshold for concern (TTC)
  • Learn the concept of Permitted Daily Allowance
  • Influence and motivate cross-functional colleagues to embrace their critical roles in successful genotoxic impurities evaluation programs

Course Level - Basic

Who Should Attend    

  • Project Managers
  • Regulatory Affairs
  • Pharmaceutical Development Scientists
  • Toxicologists
  • Drug Discovery Scientists
  • CMC Scientists
  • Clinical Development Scientists

Why Should You Attend

An effective evaluation of potential genotoxic impurities is essential for the overall success of any drug development program for small molecules. In this webinar expert speaker, Stefano Persiani will focus on the basics for an effective genotoxic impurities assessment. A case study will be described to further provide a focus on the concepts discussed.

  • $179.00



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