In this presentation

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Key messages

Reminder: where we came from

Progress over the past three years

Success factors and ongoing challenges

Some conclusions

Key messages

Working together for continuous improvement of health promotion and protection

Delivered:

•  Proactive monitoring

•  Faster safety issue detection

•  Faster warnings to users

•  Increased transparency

•  Engagement of stakeholders

Renewed focus on: efficiency, process improvement, and simplification

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Reminder: where we came from

Where we have come from

•  Reactive monitoring

•  Under-utilisation of structured data collection

•  Overlapping roles and responsibilities

•  Duplication of effort in efficient use of resource

•  Exclusion of patients from safety monitoring

•  Low levels of transparency

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Progress over the past three years

New pharmacovigilance legislation: Implementation priorities from 2011 to 2015

1.  Health promotion and protection

2.  Transparency and communication

3.  Simplification

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Strengthened expert advice, assessment and decision-making

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PRAC Risk Management planning: Planning of data collection and risk minimisation – supports protection and innovation

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Post-authorisation studies: better planned and better scrutinised

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Increased reporting of suspected side effects (+ by patients): PRAC advice on additional monitoring and reporting forms

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Safety signals at PRAC: Faster detection and management of new and changing safety issues

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Periodic Safety Update Reports at PRAC: integration of benefit and risk and direct application of new labelling (faster impact)

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Referrals to PRAC: major assessments delivering labelling for safe and effective use of medicines

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Medication errors: improvements to reduce the burden of harm – PRAC adoption of good practice guides

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Major increase in transparency: committee proceedings, side effect data, RMP summaries, PSUR assessment conclusions

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Success factors and ongoing challenges

Ongoing challenges

•  Complexity •  Access to data and EU-wide real-world evidence •  Quality of data •  Greater patient engagement •  Best use of resources •  Globalisation

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Success factors

•  Working together for continuous improvement of health promotion and protection

•  Renewed focus on: efficiency, process improvement, and simplification

•  Harness the opportunities of new technology and •  Harness the opportunities of real-world evidence •  Ensuring system improvements and product decisions are

evidence based •  Focus on making a positive impact

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Some conclusions

Conclusions

Working together for continuous improvement of health promotion and protection

Delivered:

•  Proactive monitoring

•  Faster safety issue detection

•  Faster warnings to users

•  Increased transparency

•  Engagement of stakeholders

Renewed focus on: efficiency, process improvement, and simplification

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•  Colleagues in the Member States who run national systems •  Committees and working parties •  EMA staff contributing to achieving our goals •  Patient and healthcare professional colleagues that report and support •  Industry for engagement and feedback •  Academia and ENCePP