the core of ert: qualification of an expert in toxicology in national training programs heidi foth...
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The core of ERT:
Qualification of an Expert in Toxicology in National training programs
Heidi FothMartin Luther University, Halle Saale
Rolf Schulte-HermannMedical University of Vienna
Status 1
fe
Basic toxicology and safety education
Status 2
Bachelor
Master
PhD
Expert in Toxicology
Multi disciplinesMono discipline
rare
some
rare
some
many
Universities
Research Centers& Universities
Enthusiasts innetworks
UniversitiesRegional /National
National /International
many
Local
Survey of Education in Toxicology
Subcommittee education EUROTOX
Chair : Nursen Basaran, Hacetteppe University, Turkey
Subcommittee Registration EUROTOX
Chair : Mumtaz Iscan, Ankara University, Turkey
Status 4
BSc Programmes with one course in Toxicology
hosted by Universities
Food Science many
Chemistry almost all
Pharmacy many
Biology almost all
Geo Science some
Environmental Engineering some
Toxicology Courses at European Universities
Toxicology – Safety Science Courses
survey of SC Education and SC Registration of EUROTOX, January 2011
BSc „Toxicology“ Finland
BSc „Pharmacology“ UK
BSc „Environmental Health“ UK, Sweden
BSc „Environmental Studies“ UK
Status 5
Education and Teaching in Modules
time and workload weighted by ECT‘s *
BSc degree by 180 ECTs
3 yr full term work means 30 ECTs per term
weekly work load 60 hrs forlecturesseminarspractical coursesself learning by written reportsself learning to follow up of contents
written exam
ECTs (yes/no) + final grades + ranking in academic year
* European Credit Transfer system 1 credit needs 30 hrs work
Status 6
Basic education under Bologna rules
MSc Programmes in Toxicology
Status 7
MSc 120 ECTs; 2 yr full term (*3 yr part term)
Toxicology Finland, Germany, Sweden,Turkey
Austria * (60 + 120 ECTs)
Ecotoxicology France, Czech
Toxicology and NetherlandsEnvironmental Health
Human Toxicology France
Risk assessment France
Environmental Toxicology Norway
Status 8
MSc programmes in or related to Toxicology
Status
MSc 120 ECTs; 2 yr full term
Environmental Science Finland
Inland Water Norway
Physical and Technical Environment Sweden
Environmental Chemistry Sweden
Environmental (Sanitation) Management Belgium, UK
Risk and Environmental Modelling Netherlands
Status 9
Other Toxicology Master Programmes, 1 yr
Environmental Science Finland
Inland Water Norway
Physical and Technical Environment Sweden
Environmental Chemistry Sweden
Environmental (Sanitation) Management Belgium, UK
Risk and Environmental Modelling Netherlands
Toxicology UK
Applied Toxicology UK
established in
• Austria Vienna
• Finland Oulu
• Germany Berlin, Düsseldorf, Kaiserslautern
• United Kingdom Surrey
• Sweden Stockholm
• Turkey Ankara
2 year Master of Science programes
Status 11
Pharmaceutical Toxicology
Level: MSc and PhD Special Subjects in Toxicology Toxicity of Inorganic Substances Pharmaceutical Toxicology Seminars II Toxicity Testing Methods I Toxicity Testing Methods II General Concepts and Principles in Pediatric Toxicology Immunotoxicology Extrahepatic Metabolism Systemic Metabolism and its Toxicologic Outcomes Genetic Toxicology and Techniques Basic Principles in Forensic Toxicology
University of Hacettepe/Ankara/Gazi, Faculty
of Pharmacy
Status 12
University of Surrey, Faculty of Health & Medical Sciences
Course Work includes:
Seminars (oral)
Pathology 'spot slide test' (practical microscopy)
Practical Reports (written)
Essays, problem solving and & data handling (written)
Data Interpretation & Safety Evaluation Exercise
Intramodular tests (short answers, problems and essays)
Toxicity Testing Study (written study report, oral presentation
and oral examination)
MSc in Toxicology since 1973Two semesters with 15 weeks, 4 months practical work
Collaboration with GlaxoSmithKline, Pfizer, Unilever
Status 13
MSc in Toxicology, University of Surrey, UK
Principles of Toxicology 1: Cell and molecular biology; cellular signalling;
tissue damage and repair; mutagenesis and carcinogenesis.Principles of Toxicology 2: Xenobiotic metabolism and biological systems
as drug targets; general mechanisms of toxicity and pharmacokinetics.
Target Organ Toxicity 1: Haematopoietic and immune system; liver and kidney
Target Organ Toxicity 2: Respiratory, cardiovascular, endocrine, alimentary,
integumentary and nervous systems; reproductive system and development
Assessment of Toxicity 1: Medical toxicology and principles of experimental
design in risk assessment.
Assessment of Toxicity 2: Hazard identification and risk assessment (human,
veterinary and environmental).
Practical Toxicology 1 Techniques in toxicology.
Practical Toxicology 2
Practical toxicity testing study
Integrative Skills in ToxicologyAlso part of postgraduate Diploma
Status 14
First Summary
BScteaching needs time„Bologna“s impact(swallow information – work on own – Internet information)borders between disciplines are vague
focus on technical themes – risk – environment
MScmost are non-consectivediverse programmes and nominationsfocus on technical/scientific issuesintroduction into regulation
? Sustainability in Faculty ? Understanding of keywords ? ? Time for communication ? Time for own training ?
Post graduate education
The following examples are from
Austria
Germany
Netherlands
United Kingdom
Status 16
Modules:•Laboratory animal science, animal welfare•Experimental design, statistics, biometry•Cell and molecular biology and toxicology•Morphology, physiology, biochemistry, pharmacology. Organ toxicology. Laboratory diagnostics•Toxicologic pathology•Epidemiology•Chemical and physical analysis•Toxicokinetics and metabolism•Chemical mutagenesis•Chemical carcinogenesis•Reproduction toxicology•Immunotoxicology, allergy•Clinical and forensic toxicology•Ecotoxicology•Regulatory toxicology
ECT-CREDITS:
Toxicological work 120,
Master’s thesis 15,
Modules 45 credits
Postgraduate Education Austria, Vienna
Status 17
The continuous professional development program is running since 1986
supervison by Education Committeecourses contentapproval of CV based applicationsfinal oral exam
Structure Theoretical curriculum in 14 topics (one week followed by exam) overtraining on the job in certified institutes/ institutions
(5 years) CV based application to an approval body (Education Committee) Final oral exam by the committeeFaculty
Lecturers for the courses are experienced Senior Scientists recruited from Academia, Industry and Regulation.
At present the network of lecturers comprises more that 80 Toxicologists
“Certified Toxicologist” by German Society of Toxicology
Issues 18
CPD Courses Fachtoxikologie DGPT
Basics in Epidemiology
Organ Toxicology I & II
Molecular Cell Toxicology
LaboratoryAnimals I
Metabolism Kinetics
Chemical Carcino-genesis
Clinical Toxicology
AllergyImmuno-toxicology
ReproductiveToxicology
Regulatory Toxicology
Optional Courses2 out of 4
Ecotoxicology
Food Safety
Safety Pharmacology
Lab Animal II
Swiss Society of Toxicology
Status 19
Theoretical programme:General ToxicologyFood ToxicologyOccupational ToxicologyRisk CommunicationToxicogenomicsEpidemiologyMutagenesisCarcinogenesisEcotoxicologyCell ToxicologyPathobiologyMolecular toxicologyRisk Assessment
• Reproductive Toxicology• Laboratory animal science• Immunotoxicology• Medical, Forensic and Regulatory
Toxicology• Organ Toxicology
Practical work:Two consecutive apprenticeships of 3
months each, in applied research, risk assessment, consultancy and/or the management of toxic substances
(=1.5 ECTS = credit per module; each module 1–2 weeks)
Postgraduate Education in Toxicology (PET) Wageningen, Netherlands
Status 20
Postgraduate Courses in Applied Toxicology
Post graduate Diploma is awarded after 8 core modules plus one supplementary module
Part time Master Programme , University of Surrey
Modular systempreparatory study with distance learning material5 day intense courseconsolidation and assessment
MSc is awarded after8 core module, one supplementary moduleIntegrative final assessment in Toxicology3 additional supplementary modules of own coice or laboratory/literature project
Postgraduate Courses in Applied Toxicology
Status 21
Core modules:Carcinogenicity and MutagenicityReproductive ToxicologyToxicokinetics and MetabolismPrinciples of Toxicological PathologyPrinciples of Experimental Toxicology and Risk AssessmentTarget Organ Toxicology—Systems I: Liver, Kidney, Gastrointestinal Tract and SkinTarget Organ Toxicology—Systems II: CNS, PNS, Endocrine and Musculo-skeletal SystemsTarget Organ Toxicology—Systems III: Cardiorespiratory and Haematopoietic Systems
Supplementary ModulesAlternative Methodologies to the Use of Animals in ToxicologyBioinformatics and –omics, Biomarkers, Biopharmaceuticals, Dermal ToxicologyDesign of in vivo Studies, Ecotoxicology, Endocrine System, Food Chemical Safety Evaluation, Haematology and Clinical Biochemistry, Immunotoxicology, Inhalation Toxicology, Lesions, Repair and Mutations, Measuring and Interpreting Responses –Numerical and Human Health Data, Metabolism and Human Variation, Occupational Toxicology, Paediatric Toxicology, Plant Protection Products and Plant Biotechnology, Safety Assessment of Pharmaceutical Agents, Safety Pharmacology in Preclinical R&D´, Study Design, Quality and Interpretation, Techniques in Safety Assessment,
Status 22
Specialised Programmes Safety Sciences Toxicology are established, but• Capacity is too low• Awareness in hosting institutions is at risk• The focus has been broadened
Post graduate training• 2nd line use of courses is working • Different systems are successful• One faculty – versus Center – versus Network• But all are at certain risk for continuation
Very critical• Faculty has changed, the breath is vanishing• common understanding of content need support• available money for participants is (pre)decisive• previous cooperations have been (silently) cancelled
Second Summary
Issues 23
Third summary Where to go ?
• Harmonisation is needed, but cannot be done from scratch Solution: accept regional / national schedules, but for care common
quality
• National needs on specialisation is diverse
• Maintance of Faculty is very critical, because almost all experienced personell is evaluated by other criteria
• Common understanding on the „right“ examples and meaning of keywords is crucial
? How do safety measures work? What are the limits of concepts? What are the exemption, where it does not work
? Where are the areas for improvements? What does general society expect - what is the background
Summary of ERT Syllabus
Syllabus for ERT harmonized Requirements
Issues 25
Mandatory Courses
A 1. Animal Science incl. Ethical Rules and 3 R PrincipleA 2. Experiment Design, Biometry and StatisticsA 3. Cell and Molecular Biology and Toxicology, “Omics in Toxicology”A 4. Metabolism and Kinetics of XenobioticsA 5. General Toxicology, Predictive Toxicology A 6. Organ Toxicology and Toxicologic PathologyA 7. Exposure Assessment & Biomonitoring ,Analytic & Forensic ToxicologyA 8. Epidemiology, Toxicogenetics, and Clinical StudiesA 9. Clinical and Occupational ToxicologyA10. Mutagenesis and CarcinogenesisA11. Reproductive and Developmental Toxicology A12. Immunotoxicology A13. Risk Analysis (Risk Assessment, Management and Communication), Regulatory Toxicology
Elective Courses in ERT
A14. Computational Toxicology A15. Environmental Toxicology A16. Special Issues in Drug Safety A17. Special Issues in Safety Assessment of Food,
Cosmetics, Consumer ProductsA18. Alternative Testing Methods and their Use in
the Regulatory FrameworkA19. Nanotoxicology
Issues 27
Further requirements
Practical Awareness; period of 5 years; Personal report reviewed by senior ERT or member of National Boards
B1. Post-mortem MethodsB2. Making Observations and Records of signs in Animals or HumansB3. Principles and Techniques of Cell CultureB4. Standard Analytical Methods and Techniques B5. Design of experiments, biometric and statistical procedures B6. Determination of pharmacokinetic parameters and compound metabolismB7. Procedures in Risk Analysis
Publications or reports
C. Communication skills