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 3. EFFECTIVE GENOTOXIC IMPURITIES ASSESSMENT IN DRUG DEVELOPMENT


EFFECTIVE GENOTOXIC IMPURITIES ASSESSMENT IN DRUG DEVELOPMENT

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FACULTY: DR. STEFANO PERSIANI

Scheduled Date : February 02 2022

Scheduled Time : 3pm -  4pm ET



Description

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



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Live Webinar Drug Development Dr. Stefano Persiani
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ANALYTICAL METHOD VALIDATION UNDER GOOD LABORATORY PRACTICES (GLPS)
STATISTICAL ELEMENTS OF SAMPLE SIZE CALCULATIONS FOR NON-CLINICAL VERIFICATION
AND VALIDATION STUDIES
ANNUAL GMP MASTER CLASS FOR 2022

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