Legal and Compliance Considerations for Engaging Patients As Partners
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.
- 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
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
- Clinical Safety, Pharmacovigilance and Risk Management
- Patient Support Services
- Commercial Launch Readiness/Marketing
- Market Access Strategy
- Legal, compliance, and contracting
At the conclusion of this course, participants should be able to
- Discuss the legal, ethical, and regulatory requirements and considerations for patient engagement and contact.
- Recognize standard contracting terms used for other types of KOLs that can present challenges when engaging patient/care partner/advocate expertise.
- Explain how to integrate emerging best practices for contracting with patients/care partners/advocates into your company’s planning and processes.
- Describe appropriate expectations for compliance with current legal and regulatory requirements for engaging and contacting patients/care partners/advocates.