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TOWARDS COMPETENCY-BASED REGULATORY SCIENCES EDUCATION

Reason: Papers based on this dissertation are under review for publishing in journals.

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TOWARDS COMPETENCY-BASED REGULATORY SCIENCES EDUCATION FOR REGULATORY SCIENTISTS IN SUB-SAHARAN AFRICA

thesis
posted on 2022-07-01, 15:46 authored by Abigail A EkeigweAbigail A Ekeigwe

This research proposes a model for equitable and accessible competency-based regulatory sciences education in sub-Saharan Africa. Access to safe, quality, and effective medical products in sub-Saharan Africa is contingent on strong National Medicines Regulatory Authorities (NMRA) and a strong, highly skilled workforce of regulatory scientists. The literature acknowledges that sub-Saharan Africa has a critical skilled workforce gap in regulatory scientists and an immediate need to develop strategies for sustained human capacity development in regulatory sciences. This need is significantly heightened because of rapidly evolving advances in health and medical product technologies. And as the continent moves towards regulatory harmonization and the deployment of the African Medicines Agency, the continent needs to have a skilled and portable workforce. First, using the framework synthesis type of systematic review of the literature and the survey of experts in regulatory sciences, the research developed a comprehensive competency framework (CF) to serve as the bedrock for developing a competency-based curriculum and training. Next, an online, fully asynchronous proof-of-concept (POC) competency-based regulatory sciences education (CBRSE) module was designed and deployed based on the learning sciences theories. The purposive sampling technique recruited seventeen (n = 17) participants from the Purdue Masters’ Biotechnology Innovation and Regulatory Sciences (BIRS) African cohort to engage in the POC module. The module was evaluated using an end-of-module survey (a modified Student Assessment of Learning Gains (SALG) instrument), indices of students’ engagement, and performance assessments. The CF has eighty-eight (n = 88) competence statements in five clusters, eighty-six (n = 86) of which were ranked as mandatory and two as supplementary competencies. Fourteen (n = 14) students completed the POC module. The triangulation of results from the end-of-module survey, indices of students’ engagement, and performance assessments show that the POC module assisted students in achieving the desired competencies. The research also shows that the dialectics component of the module was not a great enabler of students’ learning. Future researchers, developmental partners, and NMRA could use the competency framework and the CBRSE module’s model to develop education and continuous professional development training in sub-Saharan Africa. 

Funding

Bill and Melinda Gates Foundation

History

Degree Type

  • Doctor of Philosophy

Department

  • Agricultural and Biological Engineering

Campus location

  • West Lafayette

Advisor/Supervisor/Committee Chair

Kari Clase

Additional Committee Member 2

Paddy Shivanand

Additional Committee Member 3

Ala Samarapungavan

Additional Committee Member 4

Loran Carleton Parker

Additional Committee Member 5

Stephen Byrn