Advancing pharmacovigilance practices : a collaborative approach through education

Abstract

Introduction: Amidst rapid technological advancements and evolving healthcare landscapes, pharmaceutical professionals encounter a myriad of complex challenges. Fostering patient-centric approaches is crucial in many practices - pharmacovigilance being a vivid example. In response to the diverse needs of the pharmaceutical ecosystem, the Malta Medicines Authority (MMA) established an academy within its auspices to support a culture of continuous professional development beyond mere policy adherence. The rationale is to explore the role of innovative educational interventions for enhancing collaboration among stakeholders in navigating regulatory practices such as pharmacovigilance. Method: In April 2023, the MMA Academy for Patient Centered Excellence and Innovation in Regulatory Sciences was licensed as a Further and Higher Educational Institution by the Malta Further and Higher Education Authority (MFHEA). The MMA Academy developed a 25-hour face-to face programme leading to an "Award in Pharmacovigilance", accredited by the MFHEA at Level 6 of the Malta/European Qualifications Framework. The course was launched in January 2024, with the engagement of local and international expert speakers, offering a comprehensive understanding of pharmacovigilance legislation, guidance, and practical considerations for ensuring medicinal product safety. Feedback was collected through an evaluation form, including a five-point psychometric Likert scale, completed by several course participants. Results: The course attracted f ull enrolment and successful completion by thirty-four {n = 34) participants from diverse entities (22 private and 12 public). All evaluation form respondents ( n = 22) expressed satisfaction with course content and willingness to consider attending future educational initiatives. Notably, 19 respondents (86.4 percent) found the information presented relevant to their practice, anticipating performance improvement. Conclusion: The keen interest observed at registration stage, positive course outcomes and encouraging feedback underscore the exigency and applicability of such educational initiatives. Collaborative synergy between national competent authorities and practicing professionals portends potential for streamlining processes and addressing gaps across industry, public and regulatory settings, for the ultimate benefit of patients.