Browsing Magister Scientiae - MSc (Pharmacy Administration and Policy Regulation) by Title
Now showing items 1-20 of 37
-
A Comprehensive Study on the Global Regulatory Requirements for the submission of a Post-Approval Change, specifically a Change in Manufacturing Site
(University of the Western Cape, 2017)Regulatory requirements for post-approval changes vary for different countries around the world. It is a challenging and costly process for pharmaceutical companies to manage changes to the approved regulatory dossier over ... -
Additional regulatory review pathways can facilitate faster dossier approvals in South Africa
(University of the Western Cape, 2019)The objective of the study was to perform a comparative review of pathways, timelines and improvements of countries with markets that the South African Health Products Authority (SAHPRA) benchmark themselves against. ... -
The availability of persons nominated for adverse drug reporting and associated challenges in Gauteng regional and district public hospitals
(University of the Western Cape, 2019)Background and Objectives: The reporting of adverse drug reactions (ADRs) is a major public health necessity. It is estimated that only six to 10 percent of all ADRs are reported worldwide. This number is far less than the ... -
Awareness regarding non-steroidal anti-inflammatory drug-related side effects in Johannesburg, South Africa
(University of Western Cape, 2021)Non-steroidal anti-inflammatory drugs (NSAIDs) are amongst the most commonly used medications globally, as they are highly effective and easily accessible. The NSAIDs are indicated for mild to moderate pain management. The ... -
Cannabidiol: A medicine, health supplement or foodstuff? Analysis of South African policies relating to the introduction of cannabidiol into the market
(University of the Western Cape, 2022)With the recent rise in the popularity of cannabidiol (CBD) around the world, there are many cultivators, manufacturers, and sellers of CBD on the market. It is sold in different dosage forms including oils, used to treat ... -
Change Management in a Biopharmaceutical Company
(University of the Western Cape, 2020)This study aimed to review the change management implemented in a Biopharmaceutical company in Cape Town in the light of existing literature on change management theory. Three main constructs were identified: process of ... -
Change Management in a biopharmaceutical company
(University of Western Cape, 2020)This study aimed to review the change management implemented in a Biopharmaceutical company in Cape Town in the light of existing literature on change management theory. Three main constructs were identified: process of ... -
Community pharmacists’ knowledge, attitude and practices on adverse drug reaction reporting in South Africa
(University of the Western Cape, 2018)Pharmacovigilance involves the management of sub-standard drugs, medication errors, ―off-licence‖ drugs, abuse and misuse, lack of efficacy, poisoning, adverse drug reactions (ADRs), drug interactions, expired stock ... -
Cost-Effectiveness of selecting an Enantiopure formulation over a racemic mixture
(University of the Western Cape, 2017)The aim of this study is to provide more information in terms of the cost-effectiveness of selecting an enantiopure formulation over a racemic mixture in the context of promoting rational use of medicines. This was done ... -
A critical review of the who global report on traditional and complementary medicine 2019: implications for harmonization of traditional and complementary medicine regulation in Africa.
(University of the Western Cape, 2022)A broad range of Traditional and Complementary Medicine (TCM) practices and products is available and accessible to the population in many countries in Africa, and worldwide. Therefore, an effective and harmonized medicines ... -
Disposal Practices for Unwanted Medicines from Households in Johannesburg
(University of the Western Cape, 2017)A mixed research method was used where quantitative research facilitated qualitative research. Three questionnaires were drafted and distributed by email to respondents in the Johannesburg area. One questionnaire was for ... -
The effect of dossier farming on medicine registration in South Africa.
(University of the Western Cape, 2020)In this study, the researcher wanted to determine the effect of dossier farming in medicine registration in South Africa by comparing the number of generic registrations of products tendered for the government for the ... -
Evaluation and comparison of current legal and regulatory framework for traditional medicines in five selected African countries: A move towards harmonization of regulation of traditional medicines in Africa.
(University of the Western Cape, 2019)Background: In Africa, traditional medicine (TM) practice has been in existence since time immemorial as the major source of pharmacotherapy. However, unlike orthodox medicines TM policies and regulations are not formalised ... -
Evaluation of reporting all types of adverse drug reactions by parents of children younger than 18 years in South Africa
(University of the Western Cape, 2019)Introduction: Medicines are created with the intention of helping patients but may be harmful to the patient by causing adverse reactions. The effect of adverse drug reactions (ADRs) on patients has become more evident ... -
Exploration of the training/educational background and the roles of regulatory affairs associates/officers in selected South African based pharmaceutical companies in Gauteng province
(University of Western Cape, 2021)Regulatory Affairs (RA), within the pharmaceutical business, could be a profession that covers different registration parameters of a pharmaceutical product. This is a profession that was developed to protect the public ... -
Exploring the factors influencing the sustainability of mobile clinics for the delivery of the expanded programme on immunisation to the rural areas of the Northern Cape.
(University of Western Cape, 2021)The Northern Cape province has not been able to achieve the 90% immunization target recommended for South Africa’s expanded programme on immunisation (EPI). The situation has been attributed to the lack of access to EPI ... -
Feasibility of an internationally recognized conformitè europëenne equivalent mark for medical devices in africa: a review of current literature
(University of the Western cape, 2024)Medical devices are crucial to health systems and are critical to addressing the disease burden of African countries. In light of the importance of diagnosis and surgical intervention in healthcare, medical devices such ... -
The impact of universal health coverage and national health expenditure on the main health determinants on central America countries and the Caribbean
(University of Western Cape, 2020)Health is considered as a sensitive marker of the sustainable development of a population. In Central America and Caribbean (CAC) region, the majority of countries are considered middle-income economies with significant ... -
Innovator Medicines Versus Generic Medicine Package Inserts Safety Amendments, the Reality in South Africa
(University of the Western Cape, 2017)Availability of clinically relevant and unbiased medicine information goes a long way in promoting rational use of medicines. The package insert (PI) is one of the sources of information utilised by healthcare professionals ... -
Investigating the Economic Impact of Mandatory Electronic Prescribing Requirements in the United States
(University of the Western Cape, 2017)Technological advancements applied to healthcare may holistically improve the economic burden of prescription medication costs. United States legislative actions requiring utilization of electronic prescribing (e-prescribing) ...
