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Legal and Compliance Considerations for Engaging Patients As Partners

Gain knowledge of how to successfully incorporate ethical, legal, and regulatory requirements into your patient engagement activities.


While there is much accumulated experience with and well-established procedures and contracting processes for engaging academic and medical experts in the work of life science companies, patients, care partners, and patient advocates bring a different type of expertise to and expectations for interactions. This course will review ethical, legal, and regulatory requirements for patient contact and engagement, as well as emerging points of consensus about fair practices for engaging patients, care partners, and patient advocates, including non-disclosure, privacy, compensation, non-exclusivity, and independence.

This module takes an average of 1.75 hours to complete.

This module is part of the DIA Patient Engagement eLearning Program and a component of the Patient Engagement Certificate Program.

Featured topics

  • Working with legal and compliance teams
  • Construct appropriate contracting terms that form a solid foundation for engaging patients, care partners, and patient advocates as partners in medical product development
  • Avoid common errors in contracting with patients/advocates that can delay or derail patient engagement projects
  • Reduce the risk of presenting terms or conditions that could impair or jeopardize relationships with key patients/advocacy organizations, or the company’s reputation with these key opinion leaders


Who should attend?

  • This program is designed for professionals involved in:

    • Patient Advocacy/Engagement/Experience/Access (Including Chief Patient Officers)
    • Patient Communications
    • Medical Affairs and Medical Communities (Including Chief Medical Officer)
    • Health Outcomes
    • Study Endpoint Development
    • Research & Development
    • Clinical Trial Design, Clinical Operations
    • Benefit-Risk Assessment
    • Regulatory
    • Clinical Safety, Pharmacovigilance and Risk Management
    • Patient Support Services
    • Commercial Launch Readiness/Marketing
    • Market Access Strategy
    • Legal, compliance, and contracting

Learning objectives

At the conclusion of this course, participants should be able to

  • Identify the legal, ethical, and regulatory requirements and considerations for patient engagement and patient contact
  • Recognize standard contracting terms used for other types of key opinion leaders (KOLs) that can present challenges when engaging patient/care partner/advocate expertise
  • Determine how to integrate emerging best practices for contracting with patients/care partners/advocates into your company’s planning and processes
  • Outline appropriate expectations for compliance with current legal and regulatory requirements for engaging and contacting patients/care partners/advocates

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