Working Group XI: Patient Involvement in Development and Safe Use of Medicines
WG Member area: to access the Working Group documents please click one of the links below:
- WGXI face-to-face meeting documents
- Background document collection
- Workplans, drafts, TC notes, other
Working Group XI – Patient Involvement
Participants at the fourth meeting of the Working Group, Basel, 16-17 October 2019
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, academia and the World Medical Association. 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.
- 1st meeting held on 19-20 April 2018 in Geneva, Switzerland (minutes)
- 2nd meeting held on 23–24 October 2018 in Berlin, Germany (minutes)
- Open meeting on patient involvement in the development and safe use of medicines, 30 April 2019 (report, with links to presentations)
- 3rd meeting held on 1-2 May 2019 in Geneva, Switzerland (minutes)
- 4th meeting held on 16-17 October 2019 in Basel, Switzerland (minutes)
- 5th meeting held on 1 April 2020 (virtual meeting) (minutes)
- 6th meeting held on 26 June 2020 (virtual meeting) (minutes)
- 7th meeting held on 11 September 2020 (virtual meeting) (minutes)
- 8th meeting held on 20-21 October 2020 (virtual meeting) (minutes)
Participants at the eigth meeting of the Working Group, virtual meeting due to the pandemic, 20-21 October 2020
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.
18 June 2021
5th meeting of the WG XII on Benefit-Risk Balance for Medicinal Products
06 May 2021
8th meeting of the Working Group XIII on Real-World Data & Evidence in Regulatory Decision-Making
26 - 27 April 2021