Multistakeholder workshop to launch consultation on European Medicines Agency (EMA) human regulatory science to 2025
The European Medicines Agency (EMA) is holding a multi-stakeholder workshop on 24 October 2018 to gather initial thoughts on the key areas for human medicines to be covered in EMA’s regulatory science to 2025.
This should facilitate a shared reflection on the key regulatory science challenges faced by the Agency's scientific committees and working parties and the opportunities to address them, an understanding of the process leading to the proposed strategic goals and core recommendations, and highlighting areas of particular relevance to various stakeholder groups in order to focus on them during the public consultation.
Participants will include patient representatives, healthcare professionals, academic infrastructures, health technology assessment (HTA) bodies, payer organisations, trade associations and regulators.
The event is by invitation only to allow for a balanced representation of the various groups of stakeholders. It will be broadcast and recorded for all interested parties to follow the proceedings.
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Agenda - Multistakeholder workshop to launch consultation on European Medicines Agency (EMA) human regulatory science to 2025 (PDF/544.58 KB)
Draft
First published: 09/10/2018
Last updated: 23/10/2018 -
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List of participants - Multistakeholder workshop to launch consultation on European Medicines Agency (EMA) human regulatory science to 2025 (PDF/144.46 KB)
First published: 08/11/2018
EMA/780447/2018 -
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Reference material - - Multistakeholder workshop to launch consultation on European Medicines Agency (EMA) human regulatory science to 2025 (PDF/1.71 MB)
First published: 08/11/2018
EMA/723198/2018 -
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Presentation - Responding to the needs of the 21st century patient: Addressing challenges and opportunities across the European regulatory framework (Hans-Georg Eichler) (PDF/910.22 KB)
First published: 08/11/2018 -
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Presentation - European Organisation for Rare Diseases (EURORDIS): The point of view of patients (Simone Boselli) (PDF/1.52 MB)
First published: 08/11/2018 -
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Presentation - Session 1.04 - Responding to the needs of the 21st century patient: Addressing challenges and opportunities across the European regulatory framework (Olga Solomon) (PDF/644.74 KB)
First published: 08/11/2018 -
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Presentation - Session 1.05 - View from European Medicines Regulatory Network (Karl Broich) (PDF/1.35 MB)
First published: 08/11/2018 -
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Presentation - Session 1.06 - Responding to the needs of the 21st century Patient: Addressing challenges and opportunities across the European regulatory framework - View from the industry (Alan Morrison) (PDF/845.62 KB)
First published: 08/11/2018 -
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Presentation - Session 2 - Catalysing the integration of science and technology in drug development - EMA’s core recommendations (Enrica Alteri) (PDF/750.23 KB)
First published: 08/11/2018 -
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Presentation - Session 3 - Driving collaborative evidence generation - Improving the scientific quality of evaluations - EMA’s core recommendations (Zaide Frias) (PDF/1.08 MB)
First published: 08/11/2018 -
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Presentation - Session 4 - Advancing patient-centred access to medicines in partnership with healthcare systems - EMA’s core recommendations (Michael Berntgen) (PDF/1.08 MB)
First published: 08/11/2018 -
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Presentation -Session 5 - Addressing emerging health threats and availability/therapeutic challenges - EMA’s core recommendations (Marco Cavaleri) (PDF/860.71 KB)
First published: 08/11/2018 -
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Presentation - Session 6 - Enabling and leveraging research and innovation in regulatory science - EMA’s core recommendations (Alison Cave) (PDF/627.13 KB)
First published: 08/11/2018