National and International Organizations, Law and Pharmaceutical Policy, approvals
| Title | Εθνικοί και Διεθνείς Οργανισμοί, Νομοθεσία και Φαρμακευτική πολιτική, εγκρίσεις / National and International Organizations, Law and Pharmaceutical Policy, approvals |
| Code | ΜΙΦΓ0012 |
| Faculty | Health Sciences |
| School | Medicine |
| Cycle / Level | 2nd / Postgraduate |
| Teaching Period | Winter |
| Coordinator | Polychronis Voultsos |
| Common | No |
| Status | Inactive |
| Course ID | 600000117 |
| Academic Year | 2018 – 2019 |
| Class Period | Winter |
| Faculty Instructors |
|
| Weekly Hours | 2 |
| Class ID | 600126234
|
Course Type 2016-2020
- Background
Course Type 2011-2015
General Foundation
Mode of Delivery
- Face to face
Digital Course Content
- e-Study Guide https://qa.auth.gr/en/class/1/600126234
- At the Website of the School:
Erasmus
The course is also offered to exchange programme students.
Language of Instruction
- Greek (Instruction, Examination)
- English (Instruction, Examination)
- Italian (Instruction, Examination)
Prerequisites
Required Courses
- ΜΙΦΑ0001 Philosophy and Ethics of Science Research and Education in Medicine
General Prerequisites
Elementary knowledge of bioethics (principles and values) and law (concepts and fundamental rules) is required.
Learning Outcomes
a) To gain essential knowledge about Bioethics and Bio-Law.
b) To know the fundamental structures of National and International Organizations related to pharmaceutical drugs, the way these Organizations work and the goals they serve.
c) To know the role of rules and norms with regard to medications (pharmaceutical drugs)at all relevant levels (research, results management, approval etc)
d) To know the essential principles of pharmaceutical drug politics and the pillars on which it is based (ethics, economy, law, sociology, political sciences etc).
e) To be able to make a balanced criticism on the existing legal framework and politics (e.g. approval) with regard to pharmaceutical drugs and to propose evidence - based amendments.
General Competences
- Make decisions
- Work in an international context
- Demonstrate social, professional and ethical commitment and sensitivity to gender issues
- Be critical and self-critical
Course Content (Syllabus)
Essential knowledge about Bioethics and Bio-Law. Fundamental structures of National and International Organizations related to pharmaceutical drugs, the way these Organizations work and the goals they serve. Role of rules and norms with regard to medications (pharmaceutical drugs)at all relevant levels (research, results management, approval etc).Rules that operate to keep safety, quality and efficacy. Essential principles of pharmaceutical drug politics and the pillars on which it is based (ethics, economy, law, sociology, political sciences etc). Developing of skills in making a balanced criticism on the existing legal framework and politics with regard to pharmaceutical drugs.
Keywords
Organizations (National / International), Law, (Bio)Ethics, Politics, Pharmaceutical Drugs (Medications)
Educational Material Types
- Notes
- Interactive excersises
- Book
Use of Information and Communication Technologies
Use of ICT
- Use of ICT in Communication with Students
Description
The teacher shall advise and assist the students on any matter related to the lesson.
Course Organization
| Activities | Workload | ECTS | Individual | Teamwork | Erasmus |
|---|---|---|---|---|---|
| Lectures | |||||
| Reading Assigment | |||||
| Written assigments | |||||
| Total |
Student Assessment
Description
During the semester the student can benefit from the following: writing a paper on a subject related to the teaching material and making a public presentation on another (different) subject related to the teaching material too. Finally, the student will take part in two-fold exams: a problem-based exam and a a classic exam (giving short answers to 10 questions)
Student Assessment methods
- Written Exam with Short Answer Questions (Summative)
- Written Assignment (Formative)
- Performance / Staging (Formative)
- Written Exam with Problem Solving (Summative)
Bibliography
Course Bibliography (Eudoxus)
Ψαρούλης Δ, Βούλτσος Π, Ιατρικό Δίκαιο. Στοιχεία Βιοηθικής. University Studio: Θεσσαλονίκη, 2010.
Additional bibliography for study
Beckett, N., Hanson, S. and Mason, S. (2013) Legal and Ethical Issues Relating to Medicinal Products, in The Textbook of Pharmaceutical Medicine, 7th Edition (eds J. P. Griffin, J. Posner and G. R. Barker), Blackwell Publishing Ltd., Oxford, UK. doi: 10.1002/9781118532331.ch32
Beauchamp, T.L., Childress, J.F. (2012) Principles of Biomedical Ethics. 7th Edition. New York ; Oxford : Oxford University Press. ISBN: 9780199924585
Last Update
24-07-2015
