https://www.um.edu.mt/library/oar/handle/123456789/477 Sun, 19 Apr 2026 20:04:22 GMT 2026-04-19T20:04:22Z https://www.um.edu.mt/library/oar/handle/123456789/145584 Title: 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. Thu, 01 Jan 2026 00:00:00 GMT https://www.um.edu.mt/library/oar/handle/123456789/145584 2026-01-01T00:00:00Z https://www.um.edu.mt/library/oar/handle/123456789/145581 Title: 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 Control Thu, 01 Jan 2026 00:00:00 GMT https://www.um.edu.mt/library/oar/handle/123456789/145581 2026-01-01T00:00:00Z https://www.um.edu.mt/library/oar/handle/123456789/145549 Title: 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. Thu, 01 Jan 2026 00:00:00 GMT https://www.um.edu.mt/library/oar/handle/123456789/145549 2026-01-01T00:00:00Z https://www.um.edu.mt/library/oar/handle/123456789/145541 Title: 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. Thu, 01 Jan 2026 00:00:00 GMT https://www.um.edu.mt/library/oar/handle/123456789/145541 2026-01-01T00:00:00Z