Study-Unit Description

Study-Unit Description


CODE PHR2109

 
TITLE Regulatory Affairs and Pharmacy Ethics

 
UM LEVEL 02 - Years 2, 3 in Modular Undergraduate Course

 
MQF LEVEL 5

 
ECTS CREDITS 4

 
DEPARTMENT Pharmacy

 
DESCRIPTION Pharmaceutical Regulatory Affairs

An introduction to pharmaceutical regulatory affairs and its historical background. The concept of quality and quality assurance and the nature and inter-relationship between quality control, quality assurance and good practice are presented. The objectives and importance of regulation in the pharmaceutical field and how it impinges on the practice of pharmacy are highlighted. The interplay between regulation and the healthcare/pharmaceutical environment, consumer protection and patient expectations is presented. An overview of global issues and the features of first and second wave markets, the world-wide regulatory dimension, main regulatory models, different approaches to regulation and implications of harmonisation are discussed.

Pharmacy Ethics

The responsibilities and obligations of the professional towards the patient and the carers, other healthcare professionals and colleagues at the workplace are presented. Discussions on the development of ethical practices in terms of professional relationship with the patient and with colleagues are undertaken. The pharmacist activity as a responsible and accountable healthcare professional participating in diagnosis, discussion on prognosis and management of a condition and in ensuring a justifiable access to health care is presented.

Study-unit Aims:

- To introduce pharmaceutical regulations, directives and guidance related to the development, manufacture, distribution and use of medicines.
- To discuss pharmacists contribution in pharmaceutical regulatory affairs.
- To introduce ethical theories, principles and norms.

Learning Outcomes:

1. Knowledge & Understanding:

By the end of the study-unit the student will be able to:
- Describe the main pharmaceutical regulations, directives and guidance which manufacturers and wholesalers are expected to follow when making and distributing medicinal products in the European Union;
- Identify ethical issues in pharmacy practice.

2. Skills:

By the end of the study-unit the student will be able to:
- Interpret pharmaceutical regulations, directives and guidance which manufacturers and wholesalers are expected to follow when making and distributing medicinal products in the European Union;
- Develop and organise processes in pharmacy to meet pharmaceutical regulatory requirements;
- Discuss ethical dilemmas, propose alternative solutions and justify decisions;
- Develop moral attitudes required in pharmacy.

Main Text/s and any supplementary readings:

- Medicines and Healthcare products Regulatory Agency. Rules and Guidance for Pharmaceutical Manufacturers and Distributors. 2007. London: Pharmaceutical Press.
- Medicines and Healthcare products Regulatory Agency. Good Pharmacovigilance Practice Guide. 2008. London: Pharmaceutical Press.
- McGraw MJ, George AN, Shearn SP, Hall RL, Haws TF. Principles of Good Clinical Practice. 2010. London: Pharmaceutical Press.
- Royal Pharmaceutical Society. Medicines, Ethics and Practice. 35th ed. 2011. London: Pharmaceutical Press.

 
STUDY-UNIT TYPE Lecture, Seminar and Tutorial

 
METHOD OF ASSESSMENT
Assessment Component/s Assessment Due Sept. Asst Session Weighting
Classwork SEM2 No 10%
Examination (2 Hours) SEM2 Yes 90%

 
LECTURER/S Maresca Attard Pizzuto
Lilian Wismayer

 

 
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 2023/4. It may be subject to change in subsequent years.

https://www.um.edu.mt/course/studyunit