Regulatory Workforce Development Case Study

Introduction

The human being is the vital link in any chain of operations, but is also by nature the most flexible and variable impacting on predictability, consistency, transparency and quality of decisions. Predictably, the low regulatory capacity in low- and middle- income countries (LIMC) is partly due to the lack of appropriately qualified, trained and experienced regulators to ensure access to quality, safe and efficacious medical products in those settings. The Institute of Medicine (IOM) report described the current mishmash of inconsistent trainings offered to LMICs as part of the problem (Riviere, Buckley, & IoM, 2012). Consequently, systematic regulatory workforce development was identified as one of the critical areas to address

Moreover, in other professions such as medicine and aviation industry, not only is the use of competences for training and professional development well established and recognized, but also the set of required competences are universally accepted and globally applicable. Similarly, taking into account the global nature of the pharmaceutical industry and the need to ensure all people are protected and have access to safe, efficacious and quality medical products, a universally applicable, adaptable, flexible global competence framework to support regulatory professionals is imperative. A competency model is defined as an organization framework that lists the competences required for effective performance in a specific job, job family, organization, function or process (Marrelli et al., 2005). Thus, the global competency framework for regulators would allow competency modelling by individual organizations regardless of functional scope to align individual capabilities with the organizational strategy and business processes.

There are various models for developing a competency framework. First, the competences were organised by type of competence i.e., (A) personal effectiveness, technical capacity and (B) leadership. Second, the competences for a regulator were classified at three levels, (1) general, basic or foundational competences, (2) functional competences and (3) advanced functional competences. For each competence, stages of professional development or proficiency level were defined based on the five-stage model of adult skill acquisition (Dreyfus,