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David Woolley
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ForthTox Ltd

Bio: David Woolley is Director of ForthTox Ltd and has extensive experience in using computational models and existing literature to aid pharmacological/toxicological assessments such as non-clinical overviews, ICH Q3A/B/C/D/E reviews, permitted daily exposure assessment and ICH M7 assessments. He graduated in 2005 from the University of Aberdeen with first class honours in biomedical pharmacology and completed a PhD in neuropharmacology from the same institution. He joined ForthTox in 2008 and his role covers multiple disciplines including preparing regulatory reports (for pharmaceuticals, pharmaceutical impurities, excipients and contaminations, plant protection products, agrochemicals, medical devices and chemicals), in silico analysis and review, ICH M7 audits and study monitoring.

 

David is a Diplomate of the American Board of Toxicology, a fellow of the Academy of Toxicological Sciences, a UK and European Registered Toxicologist, a fellow of the British Toxicology Society and a member of the Royal Society of Biology, Society of Toxicology (SOT), American College of Toxicology, British Pharmacology Society and Scottish Toxicology Interest Group. He is on the International Journal of Toxicology Editorial Board, is the founder of the SOT Computational Toxicology Specialty Section and is a co-author on multiple papers and Practical Toxicology Evaluation, Prediction, and Risk (Third Edition and upcoming fourth edition).

 

Abstract: Toxicological models, whether animal-based, new approach methodologies (NAMs) or computational, play a key role in the understanding of potential toxicological effects, risk assessment and patient safety as well as providing time and cost saving measures. The results of these models, philosophical underpinnings, how they can be interpreted and their use for extrapolation between and within species and patient populations will be examined. The ICH S1B guideline will be examined in the context of the described framework and the use of artificial intelligence in pharmaceutical development scrutinized.


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Date Time Local Time Room Forum Session Role Topic
2025-10-15 14:45-15:15 2025-10-15,14:45-15:15Room 3 - Guocui Hall Continuing Education Courses (CEC)

CEC06: Advanced Toxicological Topics for Study Directors of Nonclinical Studies

Speaker The use and application of in vivo, in vitro and in silico models, artificial intelligence and ICH S1B