Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop. Table of Contents Front Matter 1 Introduction 2 The Importance of Innovative Regulatory Science 3 Defining a Discipline of Regulatory Science and Core Competencies for Its Workforce 4 Education and Training of a Regulatory Science Workforce 5 Career Paths Within Academia and Industry 6 International Applications of Regulatory Science 7 Collaborative Models and New Paradigms for Supporting Regulatory Science Research and Practice References Appendix A: Workshop Agenda Appendix B: Participant Biographies