Introduction:
We propose a Foundation Brocher workshop that will convene a variety of stakeholders (patient and patient advocates; academic, and pharmaceutical representatives; government regulators; ethicists, etc.) to discuss the ethics, regulatory, and pragmatic issues in international pediatric clinical trials. We plan to focus upon the varied cultural and regulatory differences that exist in global settings, differences that need deliberation before approaches, policies, or solutions can be proffered. Importantly, the central European setting of the Brocher Foundation workshop will permit a neutral and welcoming site to entertain different (and sometime difficult) views.