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https://www.um.edu.mt/library/oar/handle/123456789/139559| Title: | An evaluation of a systematic quality signal extraction framework in medicinal products regulatory sciences |
| Authors: | Sammut, Valentina Serracino-Inglott, Anthony |
| Keywords: | Drugs -- Quality control Pharmaceutical industry -- Quality control Pharmacovigilance Drugs -- Safety measures Drug monitoring |
| Issue Date: | 2025 |
| Publisher: | University of Malta. Department of Pharmacy |
| Citation: | Sammut, V., & Serracino-Inglott, A. (2025). An evaluation of a systematic quality signal extraction framework in medicinal products regulatory sciences. Pharmacy Education, 25(4), 7. |
| Abstract: | Introduction: Effective quality assurance (QA) requires systematic identification and management of quality-related signals, yet no standardised framework currently exists to guide the process. This research presents the Systematic Quality Signal Extraction Framework (SQSEF), a structured approach to detect, categorise, and link signals with key QA principles. The framework seeks to enhance consistency in pharmaceutical regulatory QA practices whilst contributing to the pillars of good quality, safety, and efficacy of medicines. Aim: The application of the SQSEF, aims to streamline a systematic approach to the: i. Identification of QA signals ii. Classification of QA signals iii. Drive quality improvement |
| URI: | https://www.um.edu.mt/library/oar/handle/123456789/139559 |
| Appears in Collections: | Scholarly Works - FacM&SPha |
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