DIA 2019 Global Annual Meeting

How do large regulatory agencies collaborate? What are the challenges they face, in organizations with different structures and working under different legislative frameworks, in finding ways to align to facilitate and enhance global medicines development? This forum brings together pairs of experts from FDA and EMA to launch discussion in such context, with focus on several themes that will provide a foundation for discussing challenges and successes in communication and collaboration covering four areas. These include how we have collaborated on urgent public health issues (with valsartan contamination as an example) and, from there, are working to address shared goals of enhancing global focus on quality manufacturing. From a more clinical perspective, both agencies have matured in experience managing programs for advising companies on potentially important products that could address unmet medical needs, as well as scientific challenges of how to design clinical trials that will be robust and informative in that setting of urgency.

This 75-minute session will engage the audience as a priority, drawing on the extensive experience and expertise of the panel. The audience is invited to submit questions both on the topics explored. Please come prepared with your questions for the EMA/ FDA Question Time panel. You may submit questions in advance to annualmeetingprogram@diahome.org, and include “EMA/ FDA Question Time” in the subject line.