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

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Date: Kolmapäev, 16 september 2015, All day
Asukoht: European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

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...

Reference Number: EMA/292901/2015

English (EN) (138.48 KB - PDF)

Esmakordselt avaldatud: 04/08/2015 Viimati ajakohastatud: 14/12/2015

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...

Reference Number: EMA/407046/2015

English (EN) (141.22 KB - PDF)

Esmakordselt avaldatud: 14/12/2015 Viimati ajakohastatud: 14/12/2015

Towards optimising risk minimisation measures: report on European Medicines Agency’s workshop on risk minimisation measures

Reference Number: EMA/628259/2015

English (EN) (124.73 KB - PDF)

Esmakordselt avaldatud: 14/12/2015 Viimati ajakohastatud: 14/12/2015

Presentation - Objectives of the workshop (Guido Rasi)

English (EN) (105.59 KB - PDF)

Esmakordselt avaldatud: 14/12/2015 Viimati ajakohastatud: 14/12/2015

Presentation - What are risk minimisation measures and why are they imposed (Sabine Straus)

English (EN) (2.11 MB - PDF)

Esmakordselt avaldatud: 14/12/2015 Viimati ajakohastatud: 14/12/2015

Presentation - PRAC patient representative (Marco Greco)

English (EN) (1001.86 KB - PDF)

Esmakordselt avaldatud: 14/12/2015 Viimati ajakohastatud: 14/12/2015

Presentation - Practical experiences of risk minimisation (Ciara Kirke)

English (EN) (816.54 KB - PDF)

Esmakordselt avaldatud: 14/12/2015 Viimati ajakohastatud: 14/12/2015

Presentation - How does the EU Regulatory Network communicates about risk minimisation? (Viola MacoliÄ‡-Š ariniÄ‡, Juan Garcia-Burgos)

English (EN) (3.69 MB - PDF)

Esmakordselt avaldatud: 14/12/2015 Viimati ajakohastatud: 14/12/2015

Presentation - Overview of methodologies and studies evaluating risk minimisation measures (Giampiero Mazzaglia)

English (EN) (1.41 MB - PDF)

Esmakordselt avaldatud: 14/12/2015 Viimati ajakohastatud: 14/12/2015

Presentation - Feasibility and effectiveness of interventions: the valproate case study- EAN-ILAE joint task force (Marianne de Visser)

English (EN) (403 KB - PDF)

Esmakordselt avaldatud: 14/12/2015 Viimati ajakohastatud: 14/12/2015

Presentation - Patient perspectives on monitoring effectiveness of risk minimisation measures in the field of multiple sclerosis (Christoph Thalheim)

English (EN) (1.27 MB - PDF)

Esmakordselt avaldatud: 14/12/2015 Viimati ajakohastatud: 14/12/2015

Presentation - Case studies looking at regulatory action and communication – a national experience (Rafe Suvarna)

English (EN) (1.5 MB - PDF)

Esmakordselt avaldatud: 14/12/2015 Viimati ajakohastatud: 14/12/2015

Presentation - When science and regulatory action meet reality: barriers and critical success factors to managing risk and the salience of trust (Patrick Brown)

English (EN) (400.78 KB - PDF)

Esmakordselt avaldatud: 14/12/2015 Viimati ajakohastatud: 14/12/2015

Presentation - Strengthening the planning and implementation of risk minimisation (Peter Arlett)

English (EN) (470.22 KB - PDF)

Esmakordselt avaldatud: 14/12/2015 Viimati ajakohastatud: 14/12/2015

Presentation - When science and regulatory action meet reality: barriers and critical succes factors to managing risk (Peter Mol)

English (EN) (397.73 KB - PDF)

Esmakordselt avaldatud: 14/12/2015 Viimati ajakohastatud: 14/12/2015

Presentation - Take home messages (June Raine)

English (EN) (304.25 KB - PDF)

Esmakordselt avaldatud: 14/12/2015 Viimati ajakohastatud: 14/12/2015

Multimedia