TÜRKÇE
ENGLISH
Information
| Code | VTS209 |
| Name | Pharmacovigilance |
| Term | 2022-2023 Academic Year |
| Semester | 3. Semester |
| Duration (T+A) | 1-0 (T-A) (17 Week) |
| ECTS | 1 ECTS |
| National Credit | 1 National Credit |
| Teaching Language | Türkçe |
| Level | Lisans Dersi |
| Type | Normal |
| Mode of study | Yüz Yüze Öğretim |
| Catalog Information Coordinator | Dr. Öğr. Üyesi ZEYNEP ÖZDEMİR KÜTAHYA |
| Course Instructor |
Dr. Öğr. Üyesi ZEYNEP ÖZDEMİR KÜTAHYA
(A Group)
(Ins. in Charge)
|
Course Goal / Objective
Importance of drug safety, educating individuals who have sufficient knowledge about pharmacovigilance and veterinary pharmacovigilance regulations and practices
Course Content
Regulations and practices related to pharmacovigilance and veterinary pharmacovigilance, concepts related to adverse drug reactions
Course Precondition
The course has no prerequisites.
Resources
S. Oğuz Kayaalp. Principles of Clinical Pharmacology and Basic Regulations. Pelikan Yayıncılık Ltd. Şti., 2013, 5.Edition. ISBN: 978-605-5270-36-0
Notes
Doğan Fatih. Pharmacovigilance in Veterinary Medicine. Eurasian Journal of Veterinary Sciences, 2011, 27 (1): 19-25.
Course Learning Outcomes
| Order | Course Learning Outcomes |
|---|---|
| LO01 | Explains the importance of monitoring drug safety in clinical trials and post-authorisation. |
| LO02 | Defines the basic concepts and processes related to pharmacovigilance. |
| LO03 | Defines the fields of special interest in the field of pharmacovigilance. |
| LO04 | Explains adverse drug reactions and related concepts. |
| LO05 | Expresses the limitations of preclinical toxicity studies in animals to predict toxicity in humans. |
| LO06 | Explains the importance of phase IV studies in terms of toxicity studies in humans. |
| LO07 | Defines reverse drug monitoring methods in pharmacovigilance activities. |
| LO08 | Defines the concepts and aims of veterinary pharmacovigilance. |
| LO09 | Veterinerlik alanında en sık görülen advers ilaç reaksiyonlarını açıklar. |
Relation with Program Learning Outcome
| Order | Type | Program Learning Outcomes | Level |
|---|---|---|---|
| PLO01 | Bilgi - Kuramsal, Olgusal | Learns animal species and breeds, recognizes structural, functional and behavioral characteristics (anatomical, histological, physiological, biochemical, etc.). | |
| PLO02 | Bilgi - Kuramsal, Olgusal | It determines the care and nutrition alternatives for healthy aquaculture and prepares feeding programs suitable for the purpose in accordance with the cultivation patterns and expected yield characteristics of different animal species. | |
| PLO03 | Bilgi - Kuramsal, Olgusal | Determine the diagnosis and treatment protocols of diseases. | |
| PLO04 | Bilgi - Kuramsal, Olgusal | Learns basic information about chemical and biological substances to be used for prevention and treatment of diseases and their production technologies. | 4 |
| PLO05 | Bilgi - Kuramsal, Olgusal | Evaluates the efficiency of animal breeds. Learns the level of animal breeding. Able to manage an animal selection, hybridization and artificial insemination program. | |
| PLO06 | Bilgi - Kuramsal, Olgusal | Makes the most appropriate management planning for livestock enterprises. | |
| PLO07 | Bilgi - Kuramsal, Olgusal | Has knowledge about animal rights and animal owner rights. | 2 |
| PLO08 | Bilgi - Kuramsal, Olgusal | Has sufficient technology knowledge about hygienic production, production, presentation and sales of animal foods produced for human consumption and / or products of animal products. | |
| PLO09 | Bilgi - Kuramsal, Olgusal | Learns national and international laws and regulations related to veterinary medicine. | 5 |
| PLO10 | Bilgi - Kuramsal, Olgusal | A veterinary practitioner manages animal husbandry enterprises, animal husbandry scientific research centers and animal food production enterprises by utilizing the knowledge gained in the veterinary medicine education and by observing the professional principles. | 2 |
| PLO11 | Bilgi - Kuramsal, Olgusal | Recognizes all kinds of diseases that are possible in animals, uses diagnostic methods for this purpose, receives diagnostic materials if necessary and sends them to authorized laboratories and treats the diseases diagnosed by using all methods of medicine (such as interpretation of diagnostic methods results, drug or operative applications). It takes necessary security measures including biosecurity for the control of infectious diseases. | |
| PLO12 | Bilgi - Kuramsal, Olgusal | Prepares and uses the theoretical maintenance-feed protocols. Makes necessary applications for economic aquaculture by considering the characteristics at the business and regional level. | |
| PLO13 | Bilgi - Kuramsal, Olgusal | Inspects the production of animal foods and products of animal origin which produced for human consumption and performs health control of the final foodstuffs. | 1 |
| PLO14 | Bilgi - Kuramsal, Olgusal | Being aware of the duties and responsibilities to have the consciousness of exercising the profession. Takes responsibility in individual and group work, fulfills the task in line with the skills. | 5 |
| PLO15 | Bilgi - Kuramsal, Olgusal | In cooperation with other experts in problems outside the field of expertise, the team contributes to the solution as a member. Also trying to find solutions to common problems at the regional or national level as well as communication with other professionals. | 5 |
| PLO16 | Beceriler - Bilişsel, Uygulamalı | Comprehends the methods of producing and using scientific knowledge. Evaluates the knowledge and skills gained in a critical way, identifies the new information and information sources that should be acquired in relation to the field and participates in the activities that will meet the learning needs. | 5 |
| PLO17 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | Takes tasks related to the field in professional councils and organizations. Based on his professional skills and competences, he plans and realizes social projects with the awareness of society. Provides information on the problems of public and animal health related to the definition of the problem and the solution proposals and organizes events. | 5 |
| PLO18 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | He / she can continue his / her professional development and use at least one foreign language (at least European Language Portfolio B1 general level) to establish social relations. At least at the Advanced Level of European Computer Driving License, it uses computer software and other technological tools that may be needed at professional level and social relations level. He follows the world agenda closely and is sensitive to events. | 5 |
| PLO19 | Yetkinlikler - Öğrenme Yetkinliği | Be aware of the needs of the country and the region, and if necessary, guide them in their practice. It defines the subject of human, animal and animal owner rights and considers animal welfare in all its practices. They have the ethical values that are required by the profession, and defend these values when necessary. Have the competence to practice and defense, dominate the concepts of occupational safety in terms of work place and the personnel working with it. It is aware of the environmental health rules and makes practices to protect nature. The environment is sensitive to veterinary public health and zoonoses. | 5 |
| PLO20 | Yetkinlikler - Öğrenme Yetkinliği | Conceptualize the facts and events related to veterinary services; examine scientific techniques and methods, interpret the results; constructs analysis or methods for problems; provides solutions and / or treatment alternatives according to the data obtained. Follows the legislation that is updated on veterinary services and uses them when necessary. | 5 |
| PLO21 | Bilgi - Kuramsal, Olgusal | Evaluate the physiological and physiopathological conditions of animals conceptually and factually. | |
| PLO22 | Yetkinlikler - Alana Özgü Yetkinlik | Evaluates the laboratory results (hematological, biochemical, EKG, EEG, EMG, etc.) of animal diseases and applies correct diagnosis, diagnosis and treatment methods based on the data obtained. |
Week Plan
| Week | Topic | Preparation | Methods |
|---|---|---|---|
| 1 | The importance of monitoring drug safety in clinical trials and post-authorisation. | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 2 | Definition of pharmacovigilance and special fields of interest within the field of pharmacovigilance | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 3 | Activities carried out within the framework of pharmacovigilance, objectives of pharmacovigilance | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 4 | Adverse drug reactions and related concepts | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 5 | Investigation of the causal relationship of adverse drug reactions and adverse events with drug intake | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 6 | The limitations of preclinical toxicity studies in animals to predict toxicity in humans | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 7 | Importance of phase IV studies for toxicity studies in humans | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 8 | Mid-Term Exam | Ölçme Yöntemleri: Yazılı Sınav, Sözlü Sınav, Ödev |
|
| 9 | Development of pharmacovigilance systems | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 10 | Reverse drug monitoring methods in pharmacovigilance activities | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 11 | Veterinary pharmacovigilance | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 12 | Objectives of veterinary pharmacovigilance | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 13 | Veterinary pharmacovigilance activities in Europe and Turkiye | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 14 | The most common drug groups causing adverse drug reaction in veterinary medicine | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 15 | Detection, recording and reporting of drug interactions encountered in drug administration | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 16 | Term Exams | Ölçme Yöntemleri: Yazılı Sınav, Sözlü Sınav, Ödev |
|
| 17 | Term Exams | Ölçme Yöntemleri: Yazılı Sınav, Sözlü Sınav, Ödev |
Student Workload - ECTS
| Works | Number | Time (Hour) | Workload (Hour) |
|---|---|---|---|
| Course Related Works | |||
| Class Time (Exam weeks are excluded) | 14 | 1 | 14 |
| Out of Class Study (Preliminary Work, Practice) | 14 | 1 | 14 |
| Assesment Related Works | |||
| Homeworks, Projects, Others | 0 | 0 | 0 |
| Mid-term Exams (Written, Oral, etc.) | 1 | 2 | 2 |
| Final Exam | 1 | 4 | 4 |
| Total Workload (Hour) | 34 | ||
| Total Workload / 25 (h) | 1,36 | ||
| ECTS | 1 ECTS | ||