Information Package / Course Catalogue
European Union Regulation On Drugs Used For Animal Health
Course Code: VFT553
Course Type: Area Elective
Couse Group: Second Cycle (Master's Degree)
Education Language: Turkish
Work Placement: N/A
Theory: 1
Prt.: 0
Credit: 1
Lab: 0
ECTS: 2
Objectives of the Course

To learn the usage of drugs in animal health and obligatory regulations of European Union.

Course Content

There are several legal authorities in the world that regulates the drug processes in the world, in this context, usage of drugs in animal health and obligatory regulations of European Union are examined.

Name of Lecturer(s)
Learning Outcomes
1.Tolearnthe legal issues on thedrugs
2.Tolearntheprocessaboutdrugauthorisation
3.Toexamine an legal authority on drugs
4.To find out and use resources about the profession in the area.
5.To give lectures and/or presentations and discuss with professionals in the area.
Recommended or Required Reading
1.www.ema.europa.eu
2.Kaya S. (2009).Veteriner Uygulamalı Farmakoloji. Alınmıştır: Kaya S, editor. Veteriner Farmakoloji. 5 ed. Ankara: Medisan Yayınevi.
3.Kaya S. (2008). Tıbbi Botanik ve Tıbbi Bitkiler, Medisan-2008
4.Adams H.R. (1995). VeterinaryPharmacologyandTherapeutics, Iowa UniversityPress
5.Hayes, WA (2007) PrinciplesandMethods of Toxicology, 5th Edition, Taylor and Francis, London.
6.Casarett&Doull'sToxicology - The Basic Science of Poison. McGraw-HillPress
7.Gupta, R.C. VeterınaryToxicology - Basic andClinicalPrinciples. AcademicPress
Weekly Detailed Course Contents
Week 1 - Theoretical
Regulation on drugs
Week 2 - Theoretical
Pre-authorisation - post-authorisation
Week 3 - Theoretical
General guidance. Product information
Week 4 - Theoretical
Scientific advice and guidelines
Week 5 - Theoretical
Referral procedures. Maximum residue limits applicaitons
Week 6 - Theoretical
Pharmacovigilance
Week 7 - Theoretical
Regulation on drugs (Midterm exam)
Week 8 - Theoretical
Regulation on drugs
Week 9 - Theoretical
Availability (minoruses / minorspecies)
Week 10 - Theoretical
Antimicrobialresistance
Week 11 - Theoretical
Product defectsandrecalls
Week 12 - Theoretical
Paralleldistribution
Week 13 - Theoretical
Legislativeissues
Week 14 - Theoretical
Fees
Week 15 - Final Exam
Final exam
Assessment Methods and Criteria
Type of AssessmentCountPercent
Presentation1%5
Verbal Examination1%5
Midterm Examination1%20
Final Examination1%70
Workload Calculation
ActivitiesCountPreparationTimeTotal Work Load (hours)
Lecture - Theory140121
Term Project2114
Midterm Examination101120
Final Examination1718
TOTAL WORKLOAD (hours)53
Contribution of Learning Outcomes to Programme Outcomes
PÇ-1
PÇ-2
PÇ-3
PÇ-4
PÇ-5
PÇ-6
PÇ-7
PÇ-8
PÇ-9
PÇ-10
PÇ-11
PÇ-12
OÇ-1
3
2
4
3
4
5
5
3
4
5
4
3
OÇ-2
3
2
4
3
4
5
5
3
4
5
4
3
OÇ-3
3
2
4
3
4
5
5
3
4
5
4
3
OÇ-4
5
5
5
OÇ-5
4
4
5
5
5
5
Adnan Menderes University - Information Package / Course Catalogue
2026