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QA Q&A Corner: Quality Programs: Distinguishing Between Quality, Quality System, and Compliance

Individuals perceive topics related to quality and how to establish quality within an organization in various ways. Several misconceptions prevail regarding what constitutes “quality” and a “quality program.” When designing a quality program, one must distinguish between quality, quality system, and compliance. These terms are used pervasively throughout the clinical research arena, and they are […]

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Mastering Regulations in Research

What inspired your interest in the field of regulatory science? My experience as a clinical research pro­fessional greatly influenced my interest in regulatory science. With a background in human subjects protections and experience working on Phase II-IV drug studies, I devel­oped an appreciation for how regulatory science impacts the development of new treatment options. Research […]