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IIR PTI
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| Introduction to Toxicology for the Non-specialist |
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Tue 29 Jun 2010
- Wed 30 Jun 2010
(venue to be confirmed), Brussels, Belgium
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Course participants will come away with practical knowledge to improve their understanding of the breadth of this fascinting subject. Discussed will be the role of toxicology in all stages of drug development, the regulatory environment under which toxicologists work, and interpretation of tox data. Practical excercises and discussion sessions cover case studies for a wide variety of drugs and indications. Acceptable safety margins for different therapeutic areas, and how these affect the interpretation of toxicology data is also examined. Improve your confidence when interacting with toxicologists on your project team.
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Excellent Tutor - Very knowledgeable within his field with good broad overview of drug development
Regulatory Affairs Manager, AstraZeneca
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Who Will Attend?
This course is designed for all those who come into contact with toxicology data, but who are not specialist toxicologists. Participants may be from preclinical and clinical development, regulatory affairs, project management, drug safty, registration and data management. No previous knowledge of toxicology is assumed.
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Don't Miss
This 2-day course has been designed to allow those with little or no toxicology background to be able to understand, interact and communicate with toxicologists. It will cover the principles of practical and regulatory toxicology and give an insight into the ‘what, how and why’ of toxicology, toxicology jargon and the importance of toxicology in all phases of drug development. It will also provide information into what are ‘acceptable’ safety margins, show how packages for FTIM and beyond are developed and examine the interaction between pre-clinical and clinical toxicology.
The toxicologist has input into the design, performance and interpretation of toxicology studies and a good knowledge of the decisions associated with these actions (dose route, duration of study, appropriate study parameters, toxicokinetic assessment, etc) and how they can affect the development of a drug (interpretating study findings, safety margin calculations, clinical starting dose, etc) are vital for others in the project team of larger companies or indeed, for those working more in isolation in smaller companies. The course will also give an understanding into what regulatory considerations are needed from an interaction with toxicologists (use of guidelines, input into regulatory documentation, addressing regulatory agency comments, etc), particular challenges with different types of drug (biologicals, line extensions, etc) and examine new technologies (abbreviated toxicology packages to enter the clinic quickly, etc). Safety pharmacology testing will also be discussed under the umbrella of "toxicology" testing. As well as presentations, the course will be broken up with case studies allowing participant to take part in decisions toxicologists make during the drug development process.
The course will be presented by 2 experienced toxicologists with backgrounds in all aspects of drug development, from taking a drug at early stage, through clinical development and to the market and beyond.
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Course Leader
Presented by 2 experienced toxicologists from industry, each with nearly 20 years of preclinical development knowledge. Both presenters have hands-on experience of all aspects of practical and regulatory toxicology
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