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

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