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