| CODE | PHR2108 | |||||||||
| TITLE | Regulatory Affairs and Pharmacy Ethics | |||||||||
| UM LEVEL | 02 - Years 2, 3 in Modular Undergraduate Course | |||||||||
| MQF LEVEL | Not Applicable | |||||||||
| ECTS CREDITS | 2 | |||||||||
| DEPARTMENT | Pharmacy | |||||||||
| DESCRIPTION | Learning Objectives Introduction to ethical theories, principles and norms, to analyse ethical issues and to guide ethical decision-making in pharmacy practice and pharmaceutical regulatory affairs. Using a case discussion model, one learns to identify ethical issues, discuss alternative solutions and justify ones decision using carefully reasoned arguments. Through these sessions one will be able to develop moral attitudes and character traits which can subsequently be employed in pharmacy practice. Content Pharmaceutical Regulatory Affairs: Introduction to pharmaceutical regulatory affairs An overview of global issues, different approaches to regulation, first and second wave markets The European Union and free movement of goods: liberalisation of trade versus restriction and control Medicines regulation:-placing a medicinal product on the market. Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Clinical Practice (GCP) The rational use of medicinal products in terms of a regulatory framework Pharmacovigilance and post marketing surveillance National issues versus harmonization: current initiatives and developments in the regulatory field Pharmacy Ethics: Foundations of an ethics of character and virtue Pharmacy as a profession Codes of Ethics for Pharmacy and their contemporary relevance Structure of the pharmacist-patient relationship - patient as person - person as patient Pharmacist and patient: the caring relationship Inter -and intra - professional relationships Diagnosis, prognosis and benevolence communication and truth telling Decision-making and respect for patient as person Justice and access to health care Responsibility and accountability |
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| STUDY-UNIT TYPE | Lecture, Seminar and Tutorial | |||||||||
| METHOD OF ASSESSMENT |
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| LECTURER/S | Lilian M. Azzopardi (Co-ord.) Mary Ann Ciappara Anthony Serracino Inglott Lilian Wismayer Raymond Zammit |
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The University makes every effort to ensure that the published Courses Plans, Programmes of Study and Study-Unit information are complete and up-to-date at the time of publication. The University reserves the right to make changes in case errors are detected after publication.
The availability of optional units may be subject to timetabling constraints. Units not attracting a sufficient number of registrations may be withdrawn without notice. It should be noted that all the information in the description above applies to study-units available during the academic year 2025/6. It may be subject to change in subsequent years. |
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