Vision: Next Steps and Global Outreach Joan Wilmarth Blair Sr. Advisor, International Affairs Center for Biologics Evaluation and Research, FDA

The Future IDMP at critical and exciting juncture –Implementation underway by “big players” To maximize the utility and impact of the effort, global uptake desirable –Most of the regulatory world unaware/uninformed about the standards What they are and why they are useful Foundational work that has been done should minimize the resources needed to implement by smaller players 2

Messaging Content A communication divide exists between technical level and policy level It is critical that outreach communications include “lay-friendly” messaging to facilitate understanding at the policy leadership level 3

Global Regulatory Outreach International Pharmaceutical Regulators Forum (IPRF): June 2016 agreed to establish IDMP Working Group –IPRF participation has included: Brazil, Canada, China, EMA/EC, India, Japan, Korea, Mexico, Russia, Switzerland, Taiwan but WGs have broader participation (an open forum) –Also Regional Harmonization Initiatives: APEC, ASEAN, EAC, GCC, PANDRH, SADC –Provides venue for regulatory discussions to facilitate uptake 4

FDA Regional Outreach The Americas –Short orientation/introduction of IDMP at October 2016 Conference of Pan American Drug Regulatory Harmonization –FDA and HC to open dialogue with Mexico to explore some form of engagement to facilitate COFEPRIS utilization of IDMP Could potentially serve as regional champion 5

Global Outreach: WHO WHO Uppsala Monitoring Center –Implementing IDMP standards in their adverse event monitoring system –Will result in global outreach and impact 6

In closing: Go forth and proselytize! 7