The core of ERT: Qualification of an Expert in Toxicology in National training programs

1. 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 Status

2. Basic toxicology and safety education Enthusiasts in networks Expert in Toxicology National / International Research Centers & Universities PhD rare many Regional / National fe Universities some many Master Universities Local some rare Bachelor Mono discipline Multi disciplines Status

3. Survey of Education in Toxicology Subcommittee education EUROTOX Chair : Nursen Basaran, Hacetteppe University, Turkey Subcommittee Registration EUROTOX Chair : Mumtaz Iscan, Ankara University, Turkey

4. Toxicology Courses at European Universities 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 Status

5. Toxicology – Safety Science Courses BSc „Toxicology“ Finland BSc „Pharmacology“ UK BSc „Environmental Health“ UK, Sweden BSc „Environmental Studies“ UK Status survey of SC Education and SC Registration of EUROTOX, January 2011

6. Basic education under Bologna rules • Education and Teaching in Modules • time andworkloadweightedbyECT‘s * • BScdegreeby 180 ECTs • 3 yrfulltermworkmeans 30 ECTs per term • weeklyworkload 60 hrsfor • lectures • seminars • practicalcourses • selflearningbywrittenreports • selflearningtofollowupofcontents • writtenexam • ECTs (yes/no) + final grades + ranking in academicyear * European Credit Transfer system 1 credit needs 30 hrs work Status

7. MSc Programmes in Toxicology MSc 120 ECTs; 2 yr full term (*3 yr part term) Toxicology Finland, Germany, Sweden, Turkey Austria * (60 + 120 ECTs) Human Toxicology France Toxicology and Netherlands Environmental Health Environmental Toxicology Norway Ecotoxicology France, Czech Risk assessment France Status

8. MSc programmes in or related to Toxicology MSc 120 ECTs; 2 yr full term Environmental Science Finland Environmental Chemistry Sweden Physical and Technical Environment Sweden Inland Water Norway Environmental (Sanitation) Management Belgium, UK Risk and Environmental Modelling Netherlands Status Status

9. Other Toxicology Master Programmes, 1 yr Toxicology UK Applied Toxicology UK Environmental Science Finland Environmental Chemistry Sweden Physical and Technical Environment Sweden Inland Water Norway Environmental (Sanitation) Management Belgium, UK Risk and Environmental Modelling Netherlands Status

10. 2 year Master of Science programes • established in • Austria Vienna • Finland Oulu • Germany Berlin, Düsseldorf, Kaiserslautern • United Kingdom Surrey • Sweden Stockholm • Turkey Ankara

11. University of Hacettepe/Ankara/Gazi, Faculty of Pharmacy • 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 Status

12. University of Surrey, Faculty of Health & Medical Sciences MSc in Toxicology since 1973 Two semesters with 15 weeks, 4 months practical work Collaboration with GlaxoSmithKline, Pfizer, Unilever 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) Status

13. MSc in Toxicology, University of Surrey, UK • Principles of Toxicology 1: Cell and molecular biology; cellular signalling; • tissuedamage and repair; mutagenesis and carcinogenesis. • Principles of Toxicology 2: Xenobiotic metabolism and biological systems • as drugtargets; 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 Status

14. 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 ? Status

15. Post graduate education The following examples are from Austria Germany Netherlands United Kingdom

16. Postgraduate Education Austria, Vienna • 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 Status

17. “Certified Toxicologist” by German Society of Toxicology 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 Status

18. CPD Courses Fachtoxikologie DGPT Basics in Epidemiology Molecular Cell Toxicology Optional Courses 2 out of 4 Laboratory Animals I Organ Toxicology I & II Metabolism Kinetics Ecotoxicology Food Safety Chemical Carcino- genesis Allergy Immuno- toxicology Reproductive Toxicology Clinical Toxicology Safety Pharmacology Lab Animal II Regulatory Toxicology Swiss Society of Toxicology Issues

19. Postgraduate Education in Toxicology (PET) Wageningen, Netherlands • 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, riskassessment, consultancy and/or the management of toxic substances • (=1.5 ECTS = credit per module; each module 1–2 weeks) Status

20. Postgraduate Courses in Applied Toxicology Part time Master Programme , University of Surrey Modular system preparatory study with distance learning material 5 day intense course consolidation and assessment Post graduate Diploma is awarded after 8 core modules plus one supplementary module 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 Status

21. Postgraduate Courses in Applied Toxicology • 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, Status

22. Second Summary • 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 Status

23. Third summary Where to go ? • Harmonisationisneeded, but cannotbedonefromscratch • Solution: accept regional / national schedules, but forcarecommon • quality • National needs on specialisationis diverse • MaintanceofFacultyisverycritical, becausealmost all experiencedpersonell isevaluatedbyothercriteria • Common understanding on the „right“ examplesandmeaningofkeywords • iscrucial • ? How do safetymeasureswork • ? Whatarethelimitsofconcepts • ? Whataretheexemption, whereitdoes not work • ? Wherearetheareasforimprovements • ? Whatdoesgeneralsocietyexpect - whatisthebackground Issues

24. Summary of ERT Syllabus

25. Syllabus for ERT harmonized Requirements 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 Issues

26. 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

27. 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 Issues