The core of ERT: Qualification of an Expert in Toxicology in National training programs Heidi Foth Martin Luther University, Halle Saale Rolf Schulte-Hermann Medical University of Vienna Status1

fe Basic toxicology and safety education Status2 Bachelor Master PhD Expert in Toxicology Multi disciplines Mono discipline rare some rare some many Universities Research Centers & Universities Enthusiasts in networks Universities Regional / 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

Status4 BSc Programmes with one course in Toxicology hosted by Universities Food Sciencemany Chemistryalmost all Pharmacymany Biologyalmost all Geo Sciencesome Environmental Engineeringsome 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 Status5

 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 for lectures seminars practical courses self learning by written reports self learning to follow up of contents  written exam ECTs (yes/no) + final grades + ranking in academic year * European Credit Transfer system1 credit needs 30 hrs work Status6 Basic education under Bologna rules

MSc Programmes in Toxicology Status7 MSc 120 ECTs; 2 yr full term (*3 yr part term) ToxicologyFinland, Germany, Sweden, Turkey Austria *( ECTs) EcotoxicologyFrance, Czech Toxicology and Netherlands Environmental Health Human ToxicologyFrance Risk assessmentFrance Environmental ToxicologyNorway

Status 8 MSc programmes in or related to Toxicology Status MSc 120 ECTs; 2 yr full term Environmental ScienceFinland Inland WaterNorway Physical and Technical Environment Sweden Environmental Chemistry Sweden Environmental (Sanitation) Management Belgium, UK Risk and Environmental ModellingNetherlands

Status9 Other Toxicology Master Programmes, 1 yr Environmental ScienceFinland Inland WaterNorway Physical and Technical Environment Sweden Environmental Chemistry Sweden Environmental (Sanitation) ManagementBelgium, UK Risk and Environmental ModellingNetherlands ToxicologyUK Applied ToxicologyUK

established in AustriaVienna FinlandOulu GermanyBerlin, Düsseldorf, Kaiserslautern United Kingdom Surrey SwedenStockholm TurkeyAnkara 2 year Master of Science programes

Status11 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

Status12 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 1973 Two semesters with 15 weeks, 4 months practical work Collaboration with GlaxoSmithKline, Pfizer, Unilever

Status13 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 Toxicology Also part of postgraduate Diploma

Status14 First Summary BSc teaching needs time „Bologna“s impact (swallow information – work on own – Internet information) borders between disciplines are vague focus on technical themes – risk – environment MSc most are non-consective diverse programmes and nominations focus on technical/scientific issues introduction 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

Status16 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

Status17 The continuous professional development program is running since 1986 supervison by Education Committee courses content approval of CV based applications final 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 committee Faculty 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 Laboratory Animals I Metabolism Kinetics Chemical Carcino- genesis Clinical Toxicology Allergy Immuno- toxicology Reproductive Toxicology Regulatory Toxicology Optional Courses 2 out of 4 Ecotoxicology Food Safety Safety Pharmacology Lab Animal II Swiss Society of Toxicology

Status19 Theoretical programme:  General Toxicology  Food Toxicology  Occupational Toxicology  Risk Communication  Toxicogenomics  Epidemiology  Mutagenesis  Carcinogenesis  Ecotoxicology  Cell Toxicology  Pathobiology  Molecular toxicology  Risk 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

Status20 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 system preparatory study with distance learning material 5 day intense course consolidation and assessment MSc is awarded after 8 core module, one supplementary module Integrative final assessment in Toxicology 3 additional supplementary modules of own coice or laboratory/literature project

Postgraduate Courses in Applied Toxicology Status21 Core modules:  Carcinogenicity and Mutagenicity  Reproductive Toxicology  Toxicokinetics and Metabolism  Principles of Toxicological Pathology  Principles of Experimental Toxicology and Risk Assessment  Target Organ Toxicology—Systems I: Liver, Kidney, Gastrointestinal Tract and Skin  Target Organ Toxicology—Systems II: CNS, PNS, Endocrine and Musculo-skeletal Systems  Target Organ Toxicology—Systems III: Cardiorespiratory and Haematopoietic Systems Supplementary Modules Alternative Methodologies to the Use of Animals in Toxicology Bioinformatics and –omics, Biomarkers, Biopharmaceuticals, Dermal Toxicology Design 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,

Status22 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

Issues23 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 Issues25 Mandatory Courses A 1. Animal Science incl. Ethical Rules and 3 R Principle A 2. Experiment Design, Biometry and Statistics A 3. Cell and Molecular Biology and Toxicology, “Omics in Toxicology” A 4. Metabolism and Kinetics of Xenobiotics A 5. General Toxicology, Predictive Toxicology A 6. Organ Toxicology and Toxicologic Pathology A 7. Exposure Assessment & Biomonitoring,Analytic & Forensic Toxicology A 8. Epidemiology, Toxicogenetics, and Clinical Studies A 9. Clinical and Occupational Toxicology A10. Mutagenesis and Carcinogenesis A11. 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 Products A18. Alternative Testing Methods and their Use in the Regulatory Framework A19. Nanotoxicology

Issues27 Further requirements Practical Awareness; period of 5 years; Personal report reviewed by senior ERT or member of National Boards B1. Post-mortem Methods B2. Making Observations and Records of signs in Animals or Humans B3. Principles and Techniques of Cell Culture B4. Standard Analytical Methods and Techniques B5.Design of experiments, biometric and statistical procedures B6. Determination of pharmacokinetic parameters and compound metabolism B7. Procedures in Risk Analysis Publications or reports C. Communication skills