looking into the future role of the regulator as part of the global … · 2019. 9. 19. · looking...
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Looking into the future – role of
the regulator as part of the global
innovation ecosystemDr Lorraine Nolan, Chief Executive - HPRA
BIA, London
17 Sept 2019
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The Sector in Ireland
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9 OF THE TOP 10
global med tech companies
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Inside out approach
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Sensing and
Analysing
Resource and
capacity
Harnessing
industry 4.0
Collaborate,
harmonise,
develop
standards
Respond
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INSIDE OUT
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Some HPRA Mechanisms to Support Innovation
Supporting
InnovationScientific Advice
Pre-submission
meetings
Education and
Outreach
Innovation Office
Horizon Scanning
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Sensing and
Analysing
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In 2015, EMA and the EU national competent authorities strengthened their collaboration to support medicine innovation and early development of new
medicines in the EU by establishing the EU innovation network
7Joint HMA-EMA EU Innovation Network
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Harnessing industry 4.0
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Global initiatives
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Collaborate, harmonise,
develop policy
Harmonisation
Flexiblelegislation
Policy
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Responding
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Respond
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Outside in
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Policy makers
Industry
Government strategy
Patients and advocatesHealth system capabilities
Regulators
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Future
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