Currently practising regulatory affairs pharmacists-were they ready to practice at the time of graduation - An exploratory cross-section study.

Abstract

Background: The licensing or authorisation of medicines is an essential legal and regulatory procedure that permits the commercial distribution and availability of medical products and devices. Regulatory affairs pharmacists play a major role in licensing and regulating pharmaceutical products and medical devices. Therefore, it is necessary to ensure that regulatory affairs pharmacists are sufficiently competent to practise.

Objectives: This study aims to assess the readiness of currently practising regulatory affairs pharmacists at the time of graduation.

Methods: From January to April 2024, an online self-administered questionnaire was disseminated, utilising several participant recruitment approaches. The survey instrument targeted pharmacists practising regulatory affairs in the public and private sectors. It investigated competencies related to five main knowledge domains: drug discovery and development, dosage form development, ethical and legal considerations, pharmacovigilance and surveillance, and interpersonal and administrative skills. Descriptive statistical analysis was the primary approach to data analysis.

Key findings: The results revealed distinct variations in the five knowledge and skills domains, with topics within the drug discovery and development domain being the most frequently discussed topics on average. However, research participants demonstrated limited familiarity with medicines licensing ethical and legal considerations, highlighting the need for more knowledge in this crucial subject and motivating further learning in this area.

Conclusions: The study results highlighted the necessity for comprehensive training programmes that include the core competencies required for pharmacists involved in medicines licensing. Policy makers should consider listing pharmaceutical regulatory affairs as a mandatory course in formal undergraduate pharmacy academic programmes and curricula.