Practical Application of Toxicology in Drug Development 2019
Co-organized by the British Toxicology Society and the American College of Toxicology with support from Charles River Laboratories
Early Bird Registration deadline is June 1, 2019
This highly acclaimed course will provide training in toxicology as applied in drug development to scientists from all parts of the world. Participants will obtain an overall understanding of the principles of nonclinical safety evaluation with emphasis on the practical application of these principles and interpretation of nonclinical safety data. Regulatory toxicology in drug development will be emphasised, from both a European and a US perspective. Through the week the students will participate in tutored group study of regulatory cases and original data from a regulatory submission which will conclude with a half-day workshop.
The course is intended to benefit individuals from biotechnology and pharmaceutical companies and CROs working with either small or large molecules, along with those from regulatory agencies and academia who are interested in toxicology and its application in safety assessment of drugs and medical products. Early career scientists seeking more in-depth knowledge and understanding of the role of toxicology in safety assessment will benefit. It is suitable for scientists trained in ancillary disciplines (such as chemistry, biochemistry, molecular biology, medicine, etc.) making a career change to work in drug safety assessment.
Approved by the Royal Society of Biology for 96 CPD credits. Application has been made to EUROTOX for continued recognition of the course for CPD.
Course Overview
Overview of Drug Discovery and Development; Part I - Ruth Roberts, Apconix
Overview of Drug Discovery and Development; Part II - Ruth Roberts, Apconix
Pharmacology - Rob Wallis, Safety Pharmacology Consultant
Safety Pharmacology - Rob Wallis, Safety Pharmacology Consultant
Pharmacokinetics/ADME - Kunal Taskar, GSK
Organ Systems; Part I - Adam Hargreaves, Pharmcelerate
Organ Systems; Part II - Matt Jacobsen, AstraZeneca
Safety of Biotechnology Products - Lolke de Haan, MedImmune
Genetic Toxicology - George Johnson, Swansea University
Carcinogenicity - Nigel Roome, Independent Expert
Pathology - Vasanthi Mowat, Envigo
Clinical Pathology - Jo Harding and Peter Cotton, Astra Zeneca
Immunotoxicology - Marc Pallardy, Université Paris-Sud
Reproduction/Developmental Toxicology - Gary Chellman, Charles River
Risk Assessment - Ernie Harpur, Newcastle University
Regulatory Toxicology - David Jones, MHRA
Regulatory Case Studies - Tim McGovern, American College of Toxicology and David Jones MHRA
Common Technical Document preparation and Standard for Exchange of Nonclinical Data - Trish Parris and Brett Coupland, AstraZeneca
Breakout Group Discussion of Nonclinical Assessment of Drug F with Regulators - Tim McGovern, American College of Toxicology, Tanya Chambers and Leonora Simon, MHRA
Review of Nonclinical Assessment of Drug F: Regulatory Perspective - Tim McGovern, American College of Toxicology
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