OAR@UM Community:https://www.um.edu.mt/library/oar/handle/123456789/4772026-04-17T13:34:14Z2026-04-17T13:34:14ZThe contribution of signal detection in medical device vigilancehttps://www.um.edu.mt/library/oar/handle/123456789/1455842026-04-14T13:17:14Z2026-01-01T00:00:00ZTitle: The contribution of signal detection in medical device vigilance
Abstract: Introduction: The safety, quality, and efficacy of medical devices are crucial to advancing patient care and public health. Signal detection plays a pivotal role in post-market surveillance, enabling the timely identification and management of emerging safety concerns.; Aims: To determine the contribution of signal detection in promoting safe, good quality and effective medical device within a patient-centred approach.2026-01-01T00:00:00ZDevelopment of a greenness assessment tool for analytical methodshttps://www.um.edu.mt/library/oar/handle/123456789/1455812026-04-14T12:55:31Z2026-01-01T00:00:00ZTitle: Development of a greenness assessment tool for analytical methods
Abstract: Introduction: Green Analytical Chemistry (GAC), derived from Green Chemistry, focuses on the development of environmentally friendly analysis. A key challenge in green chemistry is assessing how green a chemical process or analytical method is. Although several assessment approaches exist to evaluate the environmental impact, they vary in design and often don’t fit well with Quality Control (QC) labs, underscoring the need for standardised and practical greenness assessment tools for use in QC settings.; Aim: The aim was to develop a greenness assessment tool which applies GAC within Quality Control2026-01-01T00:00:00ZCompliance in quality control reviewing processes of finished productshttps://www.um.edu.mt/library/oar/handle/123456789/1455492026-04-14T10:07:15Z2026-01-01T00:00:00ZTitle: Compliance in quality control reviewing processes of finished products
Abstract: Introduction: ◦ Quality Control (QC) documentation must be reliable and accurate to make sound batch release decisions. ◦
It must be independently reviewed in a standardised manner to ensure reliable, quality-based decisions.; Aim: ◦ To develop a tool as a checklist to assist in mitigating and reducing errors that may occur during the QC documentation reviewing process of chemical analysis of finished drug products which may impact quality, patient safety or regulatory compliance.2026-01-01T00:00:00Z3D-printing in pharmaceutical drug manufacturing : unpacking the drivers and deterrentshttps://www.um.edu.mt/library/oar/handle/123456789/1455412026-04-14T09:31:21Z2026-01-01T00:00:00ZTitle: 3D-printing in pharmaceutical drug manufacturing : unpacking the drivers and deterrents
Abstract: Introduction: Additive Manufacturing (AM), leveraging 3D printing technology, offers
transformative potential for producing personalized medicines on-demand
directly at the point-of-care (POC). The translation of AM into
regulated clinical practice could be challenging. Key obstacles include
fragmented regulatory frameworks, uncertain applicability of Good
Manufacturing Practice (GMP) standards, and persistent knowledge gaps
in risk and quality management within decentralized clinical settings.; Aims: ▫ To synthesize and critically evaluate principal challenges associated
with implementing 3D printing for pharmaceutical drug products in
decentralized settings (e.g., hospitals and community pharmacies). ▫ To examine emerging regulatory frameworks governing POC
manufacturing and generate a comprehensive understanding of
regulatory, technical and practical factors necessary for integration of
AM into pharmaceutical practice.2026-01-01T00:00:00Z