An ad hoc planning committee will plan a two-day public workshop to address needs for international harmonization of regulatory standards to support the development, evaluation and surveillance of biomedical products. Specifically, the topics at the workshop will be defined to help identify principles and potential approaches to the development or evolution of more harmonized regulatory standards. Subject matter experts will be invited to participate in the workshop to discuss and explore principles, approaches, and strategies to support and advance regulatory harmonization. The workshop will feature invited presentations and discussions that will:

• Provide an overview of the current global regulatory landscape. Identify: (a) Current organized efforts to promote and evolve harmonized standards, and examples of areas where standards are viewed as adequately harmonized; and (b) Areas of need for development or evolution of harmonized standards.
• Identify the characteristics of a well-harmonized regulation.
• Discuss principles to guide the establishment or evolution of harmonized regulations.
• Discuss options and approaches that could facilitate or underlie systemic organizational efforts to develop and/or evolve harmonized standards. Discuss potential structures, methodologies, goals, and outcomes.

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 single individually authored summary of the workshop will be prepared by a designated rapporteur based on the information gathered and the discussions held during the workshop.