European Medicines Agency Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP) and Healthcare Professionals' Organisations (HCPWP) joint meeting: workshop on risk minimisation measures
Date:
16/09/2015
Location:
European Medicines Agency, London, UK
This is a workshop on risk minimisation measures with representatives from patients', consumers' and healthcare professionals' organisations. An overview of the regulatory environment supporting the development of risk minimisation measures will be provided to participants; In addition, current practices/experience in the implementation and evaluation of the effectiveness of additional risk minimisation measures will be shared, using concrete examples. Participants will also discuss challenges and opportunities posed by the implementation and evaluation of risk minimisation measures in real life clinical practice. Registration by invitation only.
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Agenda - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: workshop on risk minim... (PDF/138.48 KB)
First published: 04/08/2015
Last updated: 14/12/2015
EMA/292901/2015 -
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List of participants of the European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: wo... (PDF/141.22 KB)
First published: 14/12/2015
Last updated: 14/12/2015
EMA/407046/2015 -
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Towards optimising risk minimisation measures: report on European Medicines Agency’s workshop on risk minimisation measures (PDF/124.73 KB)
First published: 14/12/2015
Last updated: 14/12/2015
EMA/628259/2015 -
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Presentation - Objectives of the workshop (Guido Rasi) (PDF/105.59 KB)
First published: 14/12/2015
Last updated: 14/12/2015 -
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Presentation - What are risk minimisation measures and why are they imposed (Sabine Straus) (PDF/2.11 MB)
First published: 14/12/2015
Last updated: 14/12/2015 -
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Presentation - PRAC patient representative (Marco Greco) (PDF/1001.86 KB)
First published: 14/12/2015
Last updated: 14/12/2015 -
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Presentation - Practical experiences of risk minimisation (Ciara Kirke) (PDF/816.54 KB)
First published: 14/12/2015
Last updated: 14/12/2015 -
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Presentation - How does the EU Regulatory Network communicates about risk minimisation? (Viola Macolić-Š arinić, Juan Garcia-Burgos) (PDF/3.69 MB)
First published: 14/12/2015
Last updated: 14/12/2015 -
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Presentation - Overview of methodologies and studies evaluating risk minimisation measures (Giampiero Mazzaglia) (PDF/1.41 MB)
First published: 14/12/2015
Last updated: 14/12/2015 -
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Presentation - Feasibility and effectiveness of interventions: the valproate case study- EAN-ILAE joint task force (Marianne de Visser) (PDF/403 KB)
First published: 14/12/2015
Last updated: 14/12/2015 -
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Presentation - Patient perspectives on monitoring effectiveness of risk minimisation measures in the field of multiple sclerosis (Christoph Thalheim) (PDF/1.27 MB)
First published: 14/12/2015
Last updated: 14/12/2015 -
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Presentation - Case studies looking at regulatory action and communication – a national experience (Rafe Suvarna) (PDF/1.5 MB)
First published: 14/12/2015
Last updated: 14/12/2015 -
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Presentation - When science and regulatory action meet reality: barriers and critical success factors to managing risk and the salience of trust (Patrick Brown) (PDF/400.78 KB)
First published: 14/12/2015
Last updated: 14/12/2015 -
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Presentation - Strengthening the planning and implementation of risk minimisation (Peter Arlett) (PDF/470.22 KB)
First published: 14/12/2015
Last updated: 14/12/2015 -
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Presentation - When science and regulatory action meet reality: barriers and critical succes factors to managing risk (Peter Mol) (PDF/397.73 KB)
First published: 14/12/2015
Last updated: 14/12/2015 -
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Presentation - Take home messages (June Raine) (PDF/304.25 KB)
First published: 14/12/2015
Last updated: 14/12/2015