1. Patient involvement in labeling
CIOMS WGXI- Group 2, Sub-Team #1
Meredith smith, ton de boer, FRANCOIS HOUYEZ, ravi patel, sabine strauss

2. Work to date 3 conference calls
Collection of information regarding patient labeling worldwide
Compendium of initiatives in the recent past or ongoing currently on patient labeling
Draft survey to patient groups:
Where to get your medicines information?
What information do you want to know about how to take your medicine?
How “fit for purpose” do you find the current labeling/patient labeling?
Do you think that patients have a role to play in developing patient labeling?
Feedback on survey from EURODIS

3. Outline of labeling chapter
Why is patient engagement in product labeling valuable?
Reasons why their perspective is unique, and uniquely important
State-of-the-art landscape analysis:
What countries world-wide provide patient-targeted labeling?
What type(s) of patient labeling do they provide (what format, etc)?
What are the relevant rules/regulations in place to guide the development of patient
What do these regulations say about the need for involvement of patients in the actual development of patient labeling?
Historical overview of initiatives to Improve Patient Labeling
Examples
Gaps/Needs-
Recommendations and Proposed Future Steps: “Where are/should we be going?”