• What Is patient engagement?
• Key drivers of patient engagement
• Benefits and challenges of patient engagement
• Building an engagement plan
• Compliance issues
• Evaluating the quality and impact patient engagement program
• Why partner with patient organizations?
• Who should you partner with?
• When to partner? The importance of timing
• What Is the nature of the intended partnership? Clarify the ask And the opportunity
• How? Best practices for engagement common challenges
• Examples of quality, mutually beneficial engagements
• 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
• Why is patient-focused culture important
• Determining current practices and attitudes about patient focus
• Fundamentals of organizational culture
• Approaches to influencing cultural change to encourage patient-focused behaviors
• How can culture be influenced or changed
• Strategies for embedding patient centricity in the culture
• Why evaluate patient engagement?
• What is evaluation?
• What to evaluate?
• What methods can be used in evaluating patient engagement?
• How to use and report data?
• Putting it into action
• Understanding the patient populations/communities to be served
• Working within your organization toward a patient-focused vision
• Developing a roadmap for the patient engagement function
• Building the structure of the patient engagement function
• Planning and implementation of the patient engagement program

This module is designed for professionals involved in:

• Patient Advocacy, Patient Engagement, Patient Experience and Access (Including Chief Patient Officers)
• Patient Communications
• Medical Affairs and Medical Communications (Including Chief Medical Officers)
• Health Outcomes
• Study Endpoint Development
• Clinical Trial Design and Optimization
• Clinical Research
• Clinical Operations
• Benefit-Risk Assessment
• Pharmacovigilance and Risk Management
• Medical Science Liaisons
• Regulatory Affairs and Regulatory Patient Engagement
• Clinical Safety, Pharmacovigilance and Risk Management
• Regulators and Regulatory Reviewers
• Regulatory Affairs
• Research & Development
• Commercial Launch Readiness/Marketing
• Market Access Strategy
• Legal, Compliance, and Contracting
• Digital Health/Digital Medicine
• Patient Support Services

• Describe why integration of the patient perspective is integral for drug development programs
• Determine how other companies have executed and benefited from such programs
• Define what constitutes meaningful engagement from the patient point of view
• List steps a company can take to build a culture of patient engagement, and what resources exist to help

Preparing for a Purposeful Patient Organization Partnerships
Upon completion of this module, learners should be able to:

• Recognize the rationale for partnering with patients
• Define different types of patient organizations and existing resources to help identify those whose objectives and capabilities are best positioned to align with stated project goals
• List factors to consider in timing the approach to patient organizations
• Utilize existing open source resources to reduce uncertainty about terms of and conditions for partnering activities
• Outline criteria for meaningful, quality engagements with patient organizations to guide interactions and contracting
• Analyze common challenges with partnering with patient organizations and ways to mitigate them

Legal and Compliance Considerations for Engaging Patients as Partners
At the conclusion of this course, participants should be able to

• Identify the legal, ethical, and regulatory requirements and considerations for patient engagement and 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

Creating a Patient-Focused Culture
Upon completion of this module, learners should be able to:

• Recognize the importance of patient-focused culture
• Describe approaches to determine current practices and attitudes about patient focus from leadership and key functional areas within the organization
• Recognize approaches to influencing sustainable cultural change within organizations with an overarching goal of patient-centeredness
• Identify critical stakeholders within and outside of your organization to affect culture change
• Describe the purpose of patient-centered culture in terms that are relevant to the work of diverse internal stakeholders
• Identify change management strategies toward culture change
• Discuss approaches to influencing sustainable cultural change within the organization to encourage patient-focused behaviors
• Identify strategies for making patient-focused culture change sustainable

Patient Engagement Evaluation and Metrics
Upon completion of this course, learners should be able to:

• State the importance of evaluation of patient-focused/patient engagement efforts
• Identify the key principles of evaluation
• Discuss the elements of patient-focused/patient engagement efforts that can be evaluated: Process, Quality, Outcomes, Return
• Describe the evaluation methods often used for each element of patient-focused/patient engagement efforts
• Explain the methods used to develop data sources for patient engagement evaluation
• Describe how to use the information gathered from representative patients to evaluate and validate other findings gathered from HCPs, surveys, and health economics and outcomes research (HEOR) data
• Identify analysis and reporting of patient engagement evaluation data
• Describe effective dissemination and use of results of patient engagement evaluation both with internal teams and with external (patient, patient organization) participants
• Discuss the process for developing patient engagement metrics, including setting objectives, defining expected outcomes, and identifying relevant measures

Developing a Comprehensive Patient Engagement Program
Upon completion of this module, learners should be able to:

• Determine the appropriate patient populations/communities to engage and describe their patient journey
• Describe the considerations for developing patient engagement goals and approaches that are consistent with the organization’s mission, culture, and operations.
• Identify steps to develop a strategic patient engagement model
• Outline the structure of a patient engagement function that works consistently across the lifecycle and throughout the organization
• Describe the process for planning organizational infrastructure and support for effective patient involvement at points in the medical product lifecycle where it is likely to meet patient needs and have the most meaningful impact.