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Genotoxic Impurities - Strategies for Identification and Control

12 - 13 September 2016

Radisson Blu Edwardian Grafton, London

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.

Using a combination of theory and practical case studies, the course will allow delegates to develop the knowledge needed to overcome everyday problems and enhance performance, ensuring you are employing the most appropriate analytical strategies for your products.

  • Examining in detail the new draft ICH guideline, its implications and its impact on  control strategies
  • Learning about current methods for assessing the risk posed by genotoxic impurities
  • Exploring crucial strategies for safety testing
  • Reviewing strategies for genotoxic impurity analysis
  • Practical advice for overcoming everyday problems through the use of case  studies and practical exercises

Dr Andrew Teasdale

Andrew Teasdale, PhD, has over twenty years of experience in analytical chemistry and quality assurance, Dr. Teasdale has published a number of papers relating to GIs and has been a speaker on genotoxic impurities at a number of conferences. Dr. Teasdale 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.  He is also the also the editor / author of the first book on the subject matter Genotoxic Impurities: Strategies for Identification and Control (Wiley).

This course is relevant to anyone involved in identifying / analysing / controlling / reporting of GTIs including those working in:

  • Analytical Chemistry/Validation/R&D
  • CMC
  • Development Chemistry
  • Genetic Toxicology
  • Impurities
  • Laboratory Management
  • Pharmaceutical Development
  • Regulatory Affairs
  • Safety Assessment
  • Toxicology

Course leader talking about the EMEA Guideline on the limits of Genotoxic Impurities

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