| Course Unit Title | PHARMACEUTICAL LEGISLATION,LAW & ETHICS |
| Course Unit Code | PHA502 |
| Course Unit Details | |
| Number of ECTS credits allocated | 4 |
| | Learning Outcomes of the course unit | By the end of the course, the students should be able to:- Outline and identify the pharmaceutical legislation of Cyprus and of the European Union (Directives and Regulations) concerning: medicinal products development, clinical trials in human subjects and investigational medicinal products, production and control of medicinal products, the approval procedure, wholesale and dispensing of medicinal products, pharmacovigilance, organisation, committees and objectives of European Medicines Agency (EMEA), orphan medicinal products, herbal medicinal products, medicinal products for advance therapies, paediatric medicines and relative incentives, the disposal of expired or partly used drugs, patents in drugs and medicinal appliances or devices.
- Identify general principles of ethics in drug development.
- Explain the principles of ethics for clinical trials using medicinal products.
- Explain the politics and ethics in national prices of medicinal products.
- Identify problems in the developing world and morality.
- Recognise the role of the World Health Organisation against diseases and high drug prices.
- Explain attempts for low-cost, safe and efficient medicinal products, handling and disposing expired and partly used medicines.
|
| Mode of Delivery | Face-to-face |
| Prerequisites | PHA105 | Co-requisites | NONE |
| Recommended optional program components | NONE |
| Course Contents |
· Laws governing the production and control of drugs and medicines in pharmaceutical industry; the establishment of a community pharmacy;
pharmaceutical education; the whole trade of drugs and medicines
· The European Union legislation on actions concerning drugs and medicines
· Legislation of drug illegal production and trafficking, particularly of narcotics
· Ethics and moral rules, in any position a pharmacist practices his/her profession
· WHO role and function
· Laws governing clinical trials of medicines
· EU offices on drugs, i.e. EMEA, organisation and function
· The organisation and function of the State Drug Control Offices, the Cyprus “Pharmaceutical Services”
· Process required for the approval of new drugs and medicines
· Disposal of expired or partly used drugs
· The role of the pharmacist in a community and hospital pharmacy as well as in the society.
· Laboratory: Visit to the site of Cyprus Pharmaceutical Services, visit to the hospital pharmacy and discussion about the drug and medicine function in the hospital organization, visit to the Ministry of Health, the particular office for drugs, medicines and epidemics
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| Recommended and/or required reading: |
| Textbooks | - National legislation (summaries or abstracts): Medicinal products for human use laws No 70(Ι), 2001, The pharmacy and poison laws Cap 254, The Narcotics drugs and psychotropic substances law, The Cyprus association disciplinary rules and pension funds law.
- European Union Directives (summaries or abstracts): 2001/83/EC, 2011/62/EC, 2010/84/EC,2009/53/EC, 2002/98/EC, 2003/63/EC, 2004/24/EC, 2004/27/EC, 2008/29/EC, 2009/120/EC, 2001/20/EC, 2003/94/EC, 2005/28/EC and 89/105/EEC
- European Union Regulations (summaries or abstracts): EC/726/2004, 2008/29/EC, 2009/219/EC, EC/297/95, EC/2743/98, EC/494/2003, EC/1905/2005, CONSOLIDATED VERSION 297/95, EC/312/2008, EC/249/2009, EC/540/95, EC/1662/95, EC/2141/96, EC/141/2000, EC/847/2000, EC/1084/2003, EC/1085/2003, EC/2049/2005, EC/507/2006, EC/1901/2006, EC/1902/2006, 2008/C243/01, EC/658/2007, EC/1394/2007, EC/1234/2008, EC/712/2012, EC/668/2009, EU/1235/2010
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| References | |
| Planned learning activities and teaching methods | The course is delivered to the students by means of lectures, presented in power point. Lecture notes are given to the students. |
| Assessment methods and criteria | | Coursework | 40% | | Final Exam | 60% |
|
| Language of instruction | Greek |
| Work placement(s) | NO |
