Regulation Toxicology
This record is part of
a dataset collected by the EU Commission in June-September 2018
. Some of these links will therefore die out with time.
Please see the
overview of courses maintained by ETPLAS
or contact Norecopa for more information.
Owner/Developer: Gazi University
| Country: |
Turkey |
|---|---|
| Url: |
http://gbp.gazi.edu.tr//htmlProgramHakkinda.php?baslik=1&dr=0&lang=1&ac=16&FK=85&BK=14&ders_kodu=385001882 |
| Locations: |
Turkey |
| City: |
Ankara |
| Format: |
Lecture |
| Presence: |
Mandatory, Optional / Voluntary |
| Content type: |
Theoretical |
| Duration: |
16 weeks |
| Frequency: |
Recurrent event |
| Target audience: |
Students |
| Target sectors: |
Academia |
| Educational level: |
University (Master) |
| 3rs relevance: |
Replacement |
| Topics covered: |
Computational methods |
| 3rs coverage: |
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 |
| Legislative framework: |
Directive 2010/63/EU or equivalent, REACH Regulation (EC) No 1907/2006 or equivalent, Test guidelines (OECD, ISO, etc.), Other |
| Learning outcome: |
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: |
University education Turkish National Register of Toxicology ERT accreditation http://www.eurotox.com/sub/eurotox.com/images/ert/ert-approved-courses/ERT-courses-rev29JAN18-ef.pdf and please see attached pdf file on ERT courses |
| Qualification received: |
7.5 ECTS |
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