Mutagenic impurity, London 10/10/19
This one-day joint symposium with the RSC Toxicology group will address issues and challenges associated with the implementation of ICH M7 guideline.
We present a poster A Workflow for In Silico Assessment of Genetic Toxicity and Application to Pharmaceutical Genotoxic Impurities under ICH M7: In this work we describe a screening workflow implemented in ChemTunes-ToxGPS© that can be applied in the early stages of drug development to alert process and analytical chemists to potential genotoxic compounds earlier in the development cycle than is currently possible. If genotoxicity can be identified earlier, remedial action can be taken earlier...
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The workshop will provide an excellent opportunity for dialogue, discussion and debate with speakers - several of whom have been actively involved in shaping the guidance - and the peer group in an open forum.
Delegates will be able to understand, interpret and translate into day-to-day practice the guidance relating to:
* Regulatory and pharmacopeial interpretation
* Valsartan update
* Purging update from Mirabilis consortium
* State of the art approaches to analysis of MIs
* How do I present my MI data in a regulatory submission?
This is an excellent opportunity to learn from expert speakers who have been actively involved in the development of the guidance on these key topics.
Dr Michael Burns - Lhasa
Mark Harrison - Astra Zeneca
Dr George Johnson - Cardiff University
Richard Jones - GlaxoSmithKline
Dr Henry Stemplewski - MHRA
Dr Andrew Teasdale - AstraZeneca
Dr Mike Urquhart - GlaxoSmithKline