Introduction

Residual impurities resulting from the synthetic route, the formulation, or from 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.

Learning Objectives

An effective evaluation of potential genotoxic impurities is essential for the overall success of any drug development program for small molecules. The objectives of the course are to cover and explain all these aspects of this topic. This webinar will focus on the basics for an effective genotoxic impurities assessment. A case study will be described to further provide focus on the concepts discussed.

Area Covered In The Webinar

  • 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 colleagues to participate in genotoxic impurities evaluation programs

Why should you attend?

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. It is important to understand the issues involved in the detection and assessment of genotoxic impurities early during drug development to streamline the whole program. All of those involved in drug development should have a basic understanding of the issues related to genotoxic impurities.

Who Will Benefit

  • Project managers
  • Regulatory affairs
  • Pharmaceutical development scientist
  • Toxicologists
  • Drug discovery scientists
  • CMC scientists
  • Clinical development scientists

ENROLLMENT OPTIONS

On Demand
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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 Know More

Dr. Stefano Persiani