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

Inside out approach

Sensing and

Analysing

Resource and

capacity

Harnessing

industry 4.0

Collaborate,

harmonise,

develop

standards

Respond

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INSIDE OUT

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

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

Global initiatives

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Collaborate, harmonise,

develop policy

Harmonisation

Flexiblelegislation

Policy

Responding

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Respond

Outside in

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Policy makers

Industry

Government strategy

Patients and advocatesHealth system capabilities

Regulators

Future

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