As many late stage failures and pharmaceutical and biotech recalls result from unexpected toxicity in humans, a wider understanding of this field can help identify these problems earlier in development. As a professional working with toxicologists and their data on a regular basis you must be able to communicate effectively with them - a daunting and challenging task, due to the breadth and complexity of toxicology.
This 2-day course has been designed to provide you with a deeper understanding of toxicology so you can interpret, communicate and challenge (where necessary) toxicologists and their data on pharma and biotech. You will explore where toxicology fits in the drug development cycle, understand the different disciplines and appreciate toxicology's significance from a patient safety perspective and a regulatory viewpoint. You will examine the basic science of toxicology which will support your learning of the studies that are conducted on therapeutic products. You will also examine how to interpret data - a critical skill when communicating with the wider team and your toxicologist.
This course is run by two trainers:
This trainer is Executive Director, Nonclinical Regulatory Strategy within the Global Regulatory Affairs Department at a large CRO and is based in the UK; he has a BSc (1983) and PhD (1988).
He joined the large CRO in 1998 and has over 25 years in preclinical development (CRO, UK and Belgium industry) and has wide experience with the development of many compound classes and regulatory issues/submissions; he has written numerous peer-reviewed publications (over 50) and book reviews and is a regular podium speaker/chairperson as well as a lecturer on training courses for a range of preclinical topics. He is a Registered Toxicologist and a Fellow of The British Toxicology Society (FBTS) as well as a member of the Society of Biology (formerly The Institute of Biology) (EurBiol, CBiol, MSB), Association of Inhalation Toxicologists (AIT), Drug Information Association (DIA), Toxicokinetic Discussion Group (TKDG) and The Organisation for Professionals in Regulatory Affairs (TOPRA).
He is also Associate Editor for Toxicology Reports and on the editorial board of Journal of Toxicology + Food and Chemical Toxicology + Regulatory Toxicology and Pharmacology, is on the Executive Committee of the British Toxicology Society (and Chairs the Communication Sub-Committee) and is a member of the Association of the British Pharmaceutical Industry (ABPI) Nonclinical and Biological Discovery Expert Network (NaBDEN).
This trainer is a Senior Toxicologist within a pre-clinical consultancy group based in the UK. Until recently he was an Associate Director in the Drug Safety and Metabolism department at a top 5 pharma company, heading up the Regulatory Submissions Group. He started his career working for the Medical Research Council, followed by a brief spell working at a contract laboratory. He then spent five years with Schering Agrochemicals, before joining a top 5 pharma company in 1996.
He has been study directing pre-clinical studies, study monitoring and sitting on Project teams since 1989, and more recently managing teams of Project Toxicologists and Study Monitors. His current role focuses on assisting large and small Pharma companies with their drug development and outsourcing activities.
The trainer is a European and UK Registered Toxicologist, a Fellow of the British Toxicology Society and a Member of the Society of Biology. He sat on the BTS Executive Committee as Treasurer of the Society between 2010 and 2016, and edited the Society Newsletter between 1995 and 2005. He is an Editorial Board member for the Journal of Applied Toxicology and Toxicology Reports and has published widely in peer reviewed journals, as well as editing textbooks on preclinical infusion technology.
This course is aimed at anyone who comes into contact with toxicology data but does not require specialist knowledge in this field. No previous knowledge of toxicology is assumed. It will be of particular benefit to professionals working in: