The control of genotoxic impurities is crucial for ensuring regulatory compliance. With the implementation of increasingly stringent regulations for impurity levels, it is more important than ever for drug manufacturers to employ effective strategies for identifying, analyzing, and controlling GIs in their products. This course will provide you with the latest updates on regulatory expectations, clarifying any grey areas to outline your responsibilities as the manufacturer. It will also advise on crucial aspects of risk assessments and safety testing.
Upon successful completion of this course, the delegates will be able to:
- 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
- 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
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.