Joint workshop with representatives from patients', consumers' and healthcare professionals' organisations: Regulatory and methodological standards to improve benefit-risk evaluation of medicines
This is a joint workshop with representatives from patients', consumers' and healthcare professionals' organisations. The workshop will provide an overview of current international benefit-risk initiatives as well as on the outcomes of recent EMA/CHMP benefit-risk projects. The on-going initiatives to capture patient values and preferences in benefit-risk and to translate benefit-risk regulatory decisions into product information will also be presented. Participants will have an opportunity to discuss, through practical examples, how benefit-risk models in general could support healthcare professionals and patients in the therapeutic decision-making process.Registration by invitation only.
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Agenda - EMA Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals Working Party (HCPWP) joint meeting: Workshop on regulatory and methodological stand... (PDF/96.27 KB)
First published: 06/02/2014
Last updated: 28/04/2014
EMA/796225/2013 -
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Regulatory and methodological standards to improve benefit-risk evaluation of medicines - Workshop report (PDF/214.67 KB)
First published: 28/04/2014
Last updated: 28/04/2014
EMA/141854/2014 -
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List of participants - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: Workshop... (PDF/95.58 KB)
First published: 28/04/2014
Last updated: 28/04/2014
EMA/71682/2014 -
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Presentation - Benefit-risk decisions in the licensing of medicines - Current European Union practice and challenges (Harald Enzmann) (PDF/1.19 MB)
First published: 28/04/2014
Last updated: 28/04/2014 -
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Presentation - Emerging methodological standards: Overview of current international benefit-risk initiatives (Hans Hillege) (PDF/1.85 MB)
First published: 28/04/2014
Last updated: 28/04/2014 -
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Presentation - Evaluating methods to capture stakeholder preferences (Andrea Beyer) (PDF/669.93 KB)
First published: 28/04/2014
Last updated: 28/04/2014 -
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Presentation - Translating benefit-risk information into product information (Laurent Brassart) (PDF/919.96 KB)
First published: 28/04/2014
Last updated: 28/04/2014 -
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Presentation - Outcomes of recent European Medicines Agency-Committee for Medicinal Products for Human Use (CHMP) benefit-risk project-EPAR (Francesco Pignatti) (PDF/331.64 KB)
First published: 28/04/2014
Last updated: 28/04/2014 -
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Presentation - Benefit-risk assessment throughout the drug lifecycle: future challenges? (Hans-Georg Eichler) (PDF/1.21 MB)
First published: 28/04/2014
Last updated: 28/04/2014