European Medicines Agency Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals Working Party (HCPWP) joint meeting - Workshop on regulatory and methodological standards to improve benefit/risk evaluation of medicines

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TitleEuropean Medicines Agency Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals Working Party (HCPWP) joint meeting - Workshop on regulatory and methodological standards to improve benefit/risk evaluation of medicines
Date26/02/2014 - 26/02/2014
LocationEuropean Medicines Agency, London, UK
SummaryThis 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.

All documents

Name Language First published Last updated
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 standards to improve benefit/risk evaluation of medicines (English only) 06/02/2014 28/04/2014
Regulatory and methodological standards to improve benefit-risk evaluation of medicines - Workshop report (English only) 28/04/2014  
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 on regulatory and methodological standards to improve benefit/risk evaluation of medicines (English only) 28/04/2014  
Presentation - Benefit-risk decisions in the licensing of medicines - Current European Union practice and challenges (Harald Enzmann) (English only) 28/04/2014  
Presentation - Emerging methodological standards: Overview of current international benefit-risk initiatives (Hans Hillege) (English only) 28/04/2014  
Presentation - Evaluating methods to capture stakeholder preferences (Andrea Beyer) (English only) 28/04/2014  
Presentation - Translating benefit-risk information into product informatio (Laurent Brassart) (English only) 28/04/2014  
Presentation - Outcomes of recent European Medicines Agency-Committee for Medicinal Products for Human Use (CHMP) benefit-risk project-EPAR (Francesco Pignatti) (English only) 28/04/2014  
Presentation - Benefit-risk assessment throughout the drug lifecycle: future challenges? (Hans-Georg Eichler) (English only) 28/04/2014  

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