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Knowledge, perceptions and practices of risk-based monitoring among clinical practitioners in the United States
(University of the Western Cape, 2018)
This study investigated the current knowledge, perceptions, and practices of Risk-Based Monitoring (RBM) using written and verbal responses to an ethics review board approved questionnaire. Responses were collected from ...
An investigation into the competency framework required for the responsible pharmacist in the pharmaceutical manufacturing sector in South Africa
(The University of the Western Cape, 2017)
The pharmaceutical manufacturing sector operates within a highly regulated
environment, with companies accountable to South African statutory bodies. The
responsible pharmacist (RP) is responsible for their company’s ...
Review of the effectiveness of the medicines regulatory systems in Zambia over the period 1995 to 2015
(University of the Western Cape, 2018)
Due to inadequacy of data on the effectiveness of medicines regulatory systems in Zambia, this study
was framed. The aim was to evaluate legislative provisions for medicines regulation under three legalregulatory-
frameworks ...
The use of complementary and alternative medicines in the treatment of menopausal symptoms by private healthcare patients in Pretoria, South Africa
(University of the Western Cape, 2017)
BACKGROUND
The use of complementary and alternative medicine (CAM) is widespread in the treatment of
menopausal symptoms. While observational studies indicate that CAMs can bring some relief
of symptoms, there is mixed ...
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 ...
Mobile phone applications targeted towards medicine adherence in Africa: A systematic review
(University of Western Cape, 2020)
According to the WHO (2017), non-communicable diseases (NCDs) which include
stroke, cancer, heart disease, chronic respiratory disease and diabetes is the leading
cause of death and is responsible for seventy one percent ...
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 ...
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 ...
Review of medicine registration system in Tanzania
(University of the Western Cape, 2019)
Registration of medicines is an essential function of the national medicine regulatory system
of any country. Since the start of the medicine registration system in Tanzania in early 2000s,
no systematic review has been ...
Ongoing development of guidelines for biosimilar medicines assessment in Uganda: Critical evaluation and recommendations for inclusion
(University of Western Cape, 2020)
A Biosimilar is defined as a biologic product that is similar but not identical to the reference/originator biologic product. Biologic products have raised hopes of improving the quality of life especially in the treatment ...