Data Sheet 1_Developing and validating a regulatory science competency framework for immune cell therapy: a mixed-methods study.pdf

Existing competency frameworks for regulatory science are predominantly generalist and may not adequately capture the domain-specific competencies required for immune cell therapy.</p>Objective<p>To develop and validate a consensus-based competency framework for regulatory science professionals in immune cell therapy.</p>Methods<p>An exploratory sequential mixed-methods design was employed, comprising a multi-source literature review, preliminary expert consultation, semi-structured expert interviews, and a two-round Delphi consensus process.

Experts representing academia, industry, regulatory authorities, and government/public-sector organizations participated in the preliminary consultation and interviews (n = 11) and the Delphi consensus process (n = 20). Qualitative data were analyzed using reflexive thematic analysis. Delphi responses were analyzed using descriptive statistics, the content validity ratio, and the item-level content validity index to assess content validity in Round 1, and retention agreement, importance, educational applicability, and measurability in Round 2.</p>Results<p>The final framework comprised nine core competencies and 32 sub-competencies organized into three areas: Scientific and Regulatory Foundations, Strategic Application of Regulatory Science, and Regulatory Leadership and Responsibility.