Regulation Toxicology (Regulation Toxicology)
Owner/Developer: Gazi University
01 January 0001
Mandatory, Optional / Voluntary
Partial coverage (e.g. a module)
|Details on the topic or technology covered:||
1. Week Historical perspective in regulatory toxicology
2. Week Overview to the aim of regulations and the involvement of toxicology and toxicologist in the regulations
3. Week Currently used toxicology tests and ethical concern of animal welfare in the regulations
4. Week Safety evaluation approaches in regulatory system (tiered approach)
5. Week Alternative toxicity tests, organizations for alternative test development and validation(i.e. ECVAM, ICCVAM, JACVAM)
6. Week What is REACH? Aims and the regular process to achieve these aims and priorities
7. Week Midterm exam, htask presentation
8. Week Test guidelines (i.e. OECD, ICH) and harmonization system considering the regulatory aims
9. Week Quality assurance in regulations
10. Week Regulatory organizations- i.e. EU, USA, Japan, Canada
11. Week Regulatory organizations- i.e. EU, USA, Japan, Canada
12. Week Regulatory organizations- Turkey
13. Week Regulations for pharmaceuticals, medical devices and cosmetics
14. Week Regulations for industrial chemicals, pesticides, veterinary drugs, food additives and other highlighting chemical groups
15. Week Task Presentation
16. Week Final exam
Directive 2010/63/EU or equivalent, REACH Regulation (EC) No 1907/2006 or equivalent, Test guidelines (OECD, ISO, etc.), Other
Awareness on the national and international regulations of chemicals.
Learning how to follow developments, changes in the regulations in its dynamic structure.
Competence on directives and guidelines with regards to each chemical group regulation like drugs, cosmetics, food additives.
|Accreditation body and/or authority that approved the education or training:||
Turkish National Register of Toxicology
and please see attached pdf file on ERT courses
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