Duration: 60 Minutes


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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.

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 we 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.

Areas Covered in the Session :

  • 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

Who Should Attend:

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

Course Director: DR. STEFANO PERSIANI ‎

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. Dr. Persiani was later 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 registration in several therapeutic areas. Dr. Persiani is a member of various international scientific societies, serves on the review board of numerous professional journals, and acts as an external expert for the European Commission on the 7th Framework Program, HORIZON 2020, Marie Sklodowska-Curie Individual Fellowship Program, and Innovative Medicine Initiative. He also acts as an external expert for the La Caixa Foundation (Spain) and for the Research Agency of the Check Republic.

Specialities: Drug and biopharmaceutical discovery and development; from pre-clinical to clinical Phase I, and IIa. Dr. Persiani gives courses and consults in the above fields at the University of Milan Bicocca, University of Chieti, University of Bologna, University of Rimini, Thomson Reuter, IIR, Life Sciences Strategy, Informa life sciences, Health Communication Network, Vision in Business, Pharmaceutical Training International, GRC Educators, Trainning.com, and MPG Media.