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
1
Basic toxicology and safety education
Expert in Toxicology
National /
International
rare
Regional /
National
Local
Enthusiasts in
networks
some
rare
PhD
fe
Master
Bachelor
Mono discipline
Research Centers
& Universities
many
many
Universities
some
Universities
Multi disciplines
Status
2
Survey of Education in Toxicology
Subcommittee education EUROTOX
Chair : Nursen Basaran, Hacetteppe University, Turkey
Subcommittee Registration EUROTOX
Chair : Mumtaz Iscan, Ankara University, Turkey
Toxicology Courses at European Universities
BSc Programmes with one course in Toxicology
hosted by Universities
Food Science
Chemistry
Pharmacy
Biology
Geo Science
Environmental Engineering
Status
many
almost all
many
almost all
some
some
4
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
5
Basic education under Bologna rules

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 system
Status
1 credit needs 30 hrs work
6
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
Environmental Health
Netherlands
Environmental Toxicology
Norway
Ecotoxicology
France, Czech
Risk assessment
France
Status
7
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
8
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
9
2 year Master of Science programes
established in
• Austria
Vienna
• Finland
Oulu
• Germany
Berlin, Düsseldorf, Kaiserslautern
• United Kingdom
Surrey
• Sweden
Stockholm
• Turkey
Ankara
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
11
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
12
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
Also part of postgraduate Diploma
Integrative Skills in Toxicology
Status
13
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
14
Post graduate education
The following examples are from
Austria
Germany
Netherlands
United Kingdom
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
ECT-CREDITS:
• Chemical carcinogenesis
Toxicological work 120,
• Reproduction toxicology
• Immunotoxicology, allergy
Master’s thesis 15,
• Clinical and forensic toxicology
• Ecotoxicology
Modules 45 credits
• Regulatory toxicology
Status
16
“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
17
CPD Courses Fachtoxikologie DGPT
Basics in
Epidemiology
Molecular Cell
Toxicology
Organ
Toxicology I & II
Laboratory
Animals I
Optional Courses
2 out of 4
Metabolism
Kinetics
Ecotoxicology
Food Safety
Chemical
Carcinogenesis
Clinical
Toxicology
Allergy
Immunotoxicology
Regulatory Toxicology
Reproductive
Toxicology
Safety
Pharmacology
Lab Animal II
Swiss Society of Toxicology
Issues
18
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, risk
assessment, consultancy and/or the
management of toxic substances
(=1.5 ECTS = credit per module; each module 1–2 weeks)
Status
19
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
20
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 System
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
21
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
22
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
Issues
23
Summary of ERT Syllabus
Syllabus for ERT
harmonized Requirements
Mandatory Courses
A 1.
A 2.
A 3.
A 4.
A 5.
A 6.
A 7.
A 8.
A 9.
A10.
A11.
A12.
A13.
Animal Science incl. Ethical Rules and 3 R Principle
Experiment Design, Biometry and Statistics
Cell and Molecular Biology and Toxicology, “Omics in Toxicology”
Metabolism and Kinetics of Xenobiotics
General Toxicology, Predictive Toxicology
Organ Toxicology and Toxicologic Pathology
Exposure Assessment & Biomonitoring ,Analytic & Forensic Toxicology
Epidemiology, Toxicogenetics, and Clinical Studies
Clinical and Occupational Toxicology
Mutagenesis and Carcinogenesis
Reproductive and Developmental Toxicology
Immunotoxicology
Risk Analysis (Risk Assessment, Management and Communication),
Regulatory Toxicology
Issues
25
Elective Courses in ERT
A14.
A15.
A16.
A17.
A18.
A19.
Computational Toxicology
Environmental Toxicology
Special Issues in Drug Safety
Special Issues in Safety Assessment of Food,
Cosmetics, Consumer Products
Alternative Testing Methods and their Use in
the Regulatory Framework
Nanotoxicology
Further requirements
Practical Awareness; period of 5 years;
Personal report reviewed by senior ERT or member of National Boards
B1.
B2.
B3.
B4.
B5.
B6.
B7.
Post-mortem Methods
Making Observations and Records of signs in Animals or Humans
Principles and Techniques of Cell Culture
Standard Analytical Methods and Techniques
Design of experiments, biometric and statistical procedures
Determination of pharmacokinetic parameters and compound
metabolism
Procedures in Risk Analysis
Publications or reports
C. Communication skills
Issues
27