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:
  Mittwoch, 16 September 2015, Ganztägig
• Ort:
  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

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

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

Reference Number: EMA/628259/2015

Presentation - Objectives of the workshop (Guido Rasi)

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

Presentation - PRAC patient representative (Marco Greco)

Presentation - Practical experiences of risk minimisation (Ciara Kirke)

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

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

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

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

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

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

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

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

Presentation - Take home messages (June Raine)

Multimedia