Transcript Future vision final_Joan Blair

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
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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
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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
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uptake
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
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Global Outreach: WHO
• WHO Uppsala Monitoring Center
– Implementing IDMP standards in their
adverse event monitoring system
– Will result in global outreach and impact
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In closing:
Go forth and proselytize!
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