1. Guidance for Patient Interactions
June 2018
Beverly Harrison, Sr. Director and Head, Patient Support, GMO

2. Internal Guidance for Patient Interactions Overview
“Patient” Definition
Interactions with Patients
Internal and External Compliance
Preparation for Patient Interactions
Patient Collaboration

3. “Patient” Definition
A clear definition of the patient is critical to any internal guidelines for patient interaction
Understanding who is considered a patient will ensure any interaction is compliant
Example Patient definition: “Patients include both individuals and as represented by an external organization.”

4. Interactions with Patients
Define when and where interactions with patients are acceptable
Any interaction should be well-defined, with a stated purpose and clear rationale for interacting
Transparency and documentation of any patient interaction is key
Example settings for patient interactions: community health activities, educational meetings, and other similar venues

5. Internal and External Compliance
Gain alignment with local Compliance Officers, Quality, and other relevant organizations within your company
Interactions should not address personal information or health situations
Personnel should be properly trained to interact with patients
Interactions must be consistent with standards established by local compliance
External
Interactions must comply with applicable laws
Relevant regulatory requirements must be met and maintained
Company involvement with patients should be transparent and disclosed when appropriate

6. Preparing for Patient Interactions: Example Process
Identify need for patient interaction
Define a stated purpose, rationale, and scope
Design interaction in accordance with internal guidance and applicable laws
Review and approval of interaction by compliance and relevant internal partners

7. Patient Collaboration
Working with patients on a project introduces additional complexity
Written agreement: Detailed terms of the project between both parties is required
Privacy permission: Must be obtained in advance to use the external group’s name, contact information, etc.
Releases: Appropriate releases must be obtained prior to any publication
Compliance and Governance: Must be consistent with internal compliance and relevant regulatory requirements