Ensuring regulatory compliance by controlling genotoxic impurities (GIs) is of utmost importance. As regulations governing impurity levels become increasingly strict, drug manufacturers must adopt effective approaches to identify, analyze, and manage GIs in their products. This course aims to equip participants with the most up-to-date information on regulatory expectations, providing clarity on any ambiguous areas and outlining manufacturers' responsibilities. Additionally, the course will offer guidance on essential elements of risk assessments and safety testing, enabling manufacturers to make informed decisions in this critical area.

Course Objectives:

Examine in detail the ICH M7, EMA and FDA guidelines
Review implementation strategies of the ICH guideline for new chemical entities and generics
Explore common in silico systems used and evaluate their strengths and weaknesses
Discover methods to assess potential mutagenicity impurities
Discuss the In-Vitro and In-Vivo tests available to examine mutagenic impurities
Gain the knowledge to implement a successful strategic MI analysis with minimal impact on development times

Who Should Attend?

This course has been designed so that you don't have to take much time out of the office, therefore is perfect for individuals or groups from the same department to attend at the same time. This course is relevant to anyone involved in identifying/analyzing/controlling/reporting of GTIs.

Course Outlines:

Historical perspective on the development of guidelines relating to genotoxic impurities and their relevance/relationship to ICH M7
What does ICH M7 mean? Should I be worried?
Practical implementation
Structural analysis of impurities and data interpretation
Safety testing – pre-clinical evaluation of MI related risk
Safety testing – pre-clinical evaluation of MI related risk
How to efficiently analyze mutagenic impurities – strategies to minimize development times and appropriate focus of testing

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