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 The Modular Training Programme in Applied Toxicology is a broad and flexible programme for continuing education in all aspects of chemical safety.

Why a module on Paediatric Toxicology?  Children’s health has received much attention by regulators, the scientific community and the public. This is not surprising as many drugs used to treat children have never been formally tested in paediatric clinical trials and are used “off label” at dose levels derived by adjustment from adult dose levels. Children are also a vulnerable group for environmental chemicals since they may display novel toxicities not observed in adults or may be more or less sensitive to known toxicities. There are a significant number of examples where drugs have produced markedly different results in the small child in comparison with adults, even when administered at similar mg/kg dose levels. Differences in toxicity findings between children and adults can often be explained by differences in drug metabolism and pharmaco/toxicokinetics or by potential effects on those organ systems which are still developing post-nataly.  

 To date, drugs for use in children have not undergone such extensive safety testing in young animals - tests which may predict potential issues in man.  Standard animal tests in the reproductive portfolio end with the pre- and post-natal test where the offspring are exposed via the milk to about Day 21 of age, whilst the general toxicology portfolio opens at puberty at 6 weeks of age.
To bridge this gap a whole new set of guidelines is being developed to investigate the effects of treating young animals and assess potential effects on development.  The guidelines for pharmaceuticals are matched by new regulations for assessing developmental neurotoxicity and thyroid toxicity following exposure to pesticides.

 Who should attend?  The module is intended for management scientists, regulators and study directors, and those with an interest in the pharmaceutical area of drug research. 

Qualifications:   This is a supplementary module of the Modular Training Programme. Credits from eight core modules and one supplementary module from the training programme, together with successful completion of a final examination, can lead to a Postgraduate Diploma in Applied Toxicology. Completion of three additional supplementary modules, or a laboratory or literature based project with satisfactory preparation of a dissertation and, possibly, a viva voce examination, qualifies registered candidates for the award of an MSc in Applied Toxicology. 

The Modular Training Programme in Applied Toxicology has been accredited by the Royal College of Pathologists for the award of Continuing Professional Development credits. 

Course Outline:

 Distance learning material 

Reading Lists and Reprints.  These should be covered before the participant attends the module in order to ensure a familiarity with the topic.

 Lectures, tutorials and discussions

Introduction, history and justification • Legislation: FDA/EPA • Study designs: rodent/non-rodent • Organ system development: critical periods and cross species comparison (CNS, liver, thyroid, kidney, skeletal, cardiovascular, immune system, gastrointestinal tract) • Pharmacokinetics and drug metabolism: comparison of man>animal at stages through development • Industrial perspective • Clinical perspective • Regulator’s approach.

 Case studies on the need, timing, study design and interpretation of juvenile animals studies to enhance lecture content.

Syndicate work will be used to help delegates discuss a number of issues raised. 

Learning objectives:  

 On successful completion of the module, participants should be able to : 

·         understand and appreciate the legislation that is coming into force regarding paediatric medicines;

·         investigate the potential effects of these drugs in juvenile animals compared to the adult animal;

·         investigate the potential effects on development, evaluate species differences and then extrapolate the findings to man. 

Programme speakers:  Lecturers and tutors will be leading authorities from academia, industry, regulatory agencies and private consultancies in the UK and Europe.

 Official course language:  English. 

Assessment:

There will be an optional assessment on the last day of the module.  This will include the pre-course reading material as well as all parts of the module.  Satisfactory performance in this assessment may be accredited towards the total requirement for the MSc/Postgraduate Diploma in Applied Toxicology in accordance with the regulations of the University of Surrey.

 Entrance Requirements and Registration: 

·         Participants who wish to register for the MSc/Postgraduate Diploma should have an academic qualification together with workplace experience in toxicology or a closely related field.  Application to register for a higher award will normally take place following the first or second module attended by a candidate.  Retrospective registration is permitted provided not more than 4 modules have been completed.

·         There are no formal admission requirements for participants not wishing to register for the MSc/Postgraduate Diploma, although a scientific background to at least degree level is recommended.

 Location:  University of Surrey, in Guildford, which is situated adjacent to the A3, on a direct rail link from London, and close to London Heathrow and Gatwick airports (45-60 minutes’ travelling time).

 Accommodation and Meals:  During semester times, hotel or guest house accommodation is available in and around Guildford, while during the University vacations a limited number of rooms will be available on campus. Accommodation costs are not included in the course fees.  Lunches and refreshments will be provided during the course. 

Payment is due on receipt of our invoice which will be sent approximately 8 weeks before the start of the course.  Please see Programme of Modules for current course fees.