An ad hoc committee will plan a one-day public workshop, to be convened as a collaboration between the Institute of Medicine and the Burroughs Wellcome Fund, that will discuss issues related to the development of the discipline of innovative regulatory science for medical product development, focusing on infrastructure, systems and workforce. The public workshop will feature invited presentations and discussions that will focus on: (1) the current scope and status of federal, academic, and private regulatory science strategic priorities; and (2) progress made in establishing workforce training and other infrastructure to advance the discipline of innovative regulatory science.

Subject matter experts will be invited to discuss key needs for further establishing and strengthening the discipline and to explore priorities and potential opportunities for collaboration to address those needs. The workshop will include consideration of the core components of the regulatory science infrastructure that include the workforce, process, and systems in the public and private sectors needed to foster innovation in medical product development and evaluation methodologies, with attention to the entire product development lifecycle.

The workshop will feature invited presentations and discussions that will:

• Explore current regulatory science priorities and strategies in federal, academic, and private sector settings.
• Consider the current state of regulatory science as a discipline.
  • Discuss professional training successes.
  • Highlight opportunities to further support training, workforce, and career development.
• Explore the core components of a robust discipline of innovative regulatory science.
  • Consider gaps and key opportunities to address needs to support the discipline of innovative regulatory science.
• Examine needs and barriers to collaboration among, across, and within the public and private sectors.

The planning committee will develop the agenda for the workshop, select and invite speakers and discussants, and moderate or identify moderators for the discussions. A brief workshop summary will be prepared by a designated rapporteur based on the information gathered and discussions held during the workshop in accordance with institutional guidelines.