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.
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)
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