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Advancing regulatory sciences closer to the patient care setting: a course development approach

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European Statement

Education and Research

Author(s)

Anthony Serracino Inglott, Maria Mamo, Amar Abbas, Luana Mifsud Buhagiar

Why was it done?

Regulatory science is not some detached activity performed in secluded offices but is applied by pharmacists as an integral part of their daily work, whether thought of as regulatory intelligence or not. This initiative endeavored to offer educational intervention, for streamlining a patient-centric culture and addressing gaps, while waning concerns regarding potential conflicts arising from regulator-stakeholder interactions.

What was done?

The Malta Medicines Authority (MMA), through the MMA Academy for Patient Centred Excellence and Innovation in Regulatory Sciences, implemented a course intended for collaborative synergy with professionals in patient care settings. Strengthening regulatory intelligence may provide substantial return on investment for the ultimate benefit of patients.

How was it done?

In April 2023, the MMA Academy completed registration as a Further and Higher Educational Institution. An accredited 3-day course, leading to an Award in Basic Regulatory Sciences (Malta/European Qualifications Framework Level 4), was launched across stakeholders. Twenty-four experts were engaged to deliver sessions on legislation, ethics, quality, information sources, digitalization, pharmacovigilance, good practices, risk, and avoiding victims of the system. Registrations were initially slow, owing possibly to the holiday season, increasing to maximal venue capacity following reminder mails and media posts. The course was delivered in September and feedback collected through a Likert scale evaluation exercise.

What has been achieved?

Thirty participants (8 from public, 22 from private entities) completed the course successfully. All respondents to the course evaluation exercise (n=24) expressed satisfaction with course content and willingness to attend further courses. Promisingly, 92% of same respondents found the information presented relevant to their practice, anticipating performance improvement. Feedback included recommendations for future initiatives, particularly on regulatory oversight of aesthetic medicine services and integration of artificial intelligence in hospital pharmacy practices. A continuous educational needs exchange is encouraged for course development tailored to respective patient care settings.

What next?

Interest was expressed by the Health Department (Ministry for Health, Malta) to support eligible candidates for participation, auguring well for enhanced prospective engagement by clinical pharmacists and colleagues in the state hospitals. This may also serve as example to other competent authorities. Going forward, the MMA Academy intends to invest in online provision to reach a wider audience through a virtual environment.

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