Working groups

Working Group XI: Patient Involvement in Development and Safe Use of Medicines

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Working Group XI – Patient Involvement

Participants at the first meeting of the Working Group, Geneva, 19-20 April 2018

Background

The importance of patient involvement throughout the life cycle of pharmaceutical products, from their development to their use on the market has increasingly been recognized. Patients are now invited to state their perspectives and preferences on new needed medicines, to provide input to regulatory benefit-risk assessments through public hearings and consultations, and to submit adverse reaction reports to pharmacovigilance systems using new technologies such as mobile apps or social media.

Previous CIOMS guidelines have recognized the role of patients as key stakeholders in the safe and effective use of medicines, and some input from patients themselves was obtained for the first time by the CIOMS Working Group (WG) IX when formulating its guidance on Practical Approaches for Risk Minimisation of Medicinal Products.

Working Group objectives

The CIOMS Working Group XI on patient involvement in the development and safe use of medicines was launched in April 2018. It includes participants from patient organizations, industry, regulators and academia, with potential additional representation from ethicists and Health Care Professionals. These experts are working together to formulate pragmatic Points to Consider in patient involvement. The guidance will provide a comprehensive overview of present knowledge and existing initiatives, and will address a wide range of the remaining challenges and practice gaps. The optimal consideration of patient perspectives will support the safe and effective use of medicines, thereby helping to improve the health of individuals and the public.

Progress

  • 1st meeting held on  19-20 April 2018, Geneva, Switzerland
  • 2nd meeting to be held on 23–24 October 2018, Berlin, Germany

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CIOMS Working Groups usually take 2-4 years to finalize their guidance and recommendations. Most groups hold two in-person meetings per year, with telework in between. The groups make use of collaborative efforts and capitalize on existing initiatives in order to provide output that is as comprehensive as possible, does not duplicate other efforts and has added value.

CIOMS MEETINGS

Upcoming Meetings

11 December 2018

Geneva, Switzerland

CIOMS 85th Executive Committee Meeting

27 - 28 November 2018

Aix-en-Provence, France

4th meeting of Drug Induced Liver Injury Working Group

23 - 24 October 2018

Berlin, Germany

2nd Meeting Working Group XI Patient Involvement in Developmnt/Safe Use Medicines

08 - 09 October 2018

Tallinn, Estonia

3rd meeting of Clinical Research in Resource-Limited Settings Working Group

11 - 12 September 2018

Geneva, Switzerland

14th Meeting of the Implementation Working Group on MedDRA

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