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Genotoxic Impurities - Methods to Identify and Control

4-week online academy | 2 hours per week

2020 Dates TBC

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, analysing and controlling GIs in their products.

Led by Andrew Teasdale, this 4 week 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.

This course is approved by the Royal Society of Chemistry.

Andrew Teasdale, PhD, has over twenty years’ of experience in analytical chemistry and quality assurance and has published a number of papers relating to GIs as well as presented at a number of conferences. He has also led two expert groups working in the field of genotoxic impurities, including an analytical group in the UK and a Project Quality Research Institute (PQRI) working group, which focused on the critical area of sulfonate ester formation and control. He also led sub-groups within both EFPIA and PhRMA during the development of ICH M7 and currently leads a team developing the addendum to ICH M7 which will provide definitive limits for common mutagenic reagents.

  • 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

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/analysing/controlling/reporting of GTIs.

PTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.

Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.


This course is approved by the Royal Society of Chemistry for the purpose of continuing professional development. 

As the UK’s professional body for chemical scientists, the Royal Society of Chemistry supports professional development by listing excellent training opportunities on their database of approved courses. The approval process is one of peer review, involving assessment against set criteria by members that are expert in their field.

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