Legal and Compliance Considerations for Engaging Patients as Partners eLearning Module
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Keyword(s)
Patient Engagement; Patient Advocacy; Clinical Research; Drug Development
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.Register Here
Credit Information
ACPE = 1.75
IACET = .2
IACET = .2
Description
Learning Objectives
Upon completion of this module, learners should be able to:
Upon completion of this module, learners 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
Featured Topics
- Working with legal and compliance teams
- Constructing appropriate contracting terms that form a solid foundation for engaging patients, care partners, and patient advocates as partners in medical product development
- Common errors in contracting with patients/advocates that can delay or derail patient engagement projects
- Reducing 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