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Non-clinical Development
The courses of this section will explain non-clinical studies in detail, the concepts of pharmacogenetics/g...
Clinical Development
This section contains courses on clinical development and trials, including statistics, ethics, the role of...
Patient Engagement Roadmap
The value of patient involvement in medicines research and development is increasingly recognised by all stakeholders. Unfortunately, limited formal documentation of patient involvement activities hampers the sharing of experience and learnings, preventing timely and systematic implementation.
To overcome that challenge the content of the EUPATI Patient Expert Programme has been developed following the Patient Engagement Roadmap, a process model that provides guidance for patient involvement in the different areas of the medicines R&D process.
Research Priorities
High expertise in disease area required
Setting research priorities
- Gap analysis - Early Horizon Scanning - Matching unmet needs with research
- Defining patient-relevant added value and outcomes
Research Design & Planning
High expertise in disease area required
Protocol Synopsis
- Design - Target population
Protocol Design
- Relevant endpoints - Benefit / Risk balance - In-/Exclusion criteria
- Diagnosis procedures - Quality of life and Patient Reported Outcomes (PROs)
- Ethical issues - Data protection - Mobility issues/logistics - Adherence measures
Medium expertise in disease area required
Practical Considerations
- Contractual issues - Travel expenses - Support for family members - Mobility
Patient Information
- Content - Visual design - Readability - Language - Dissemination
Informed Consent
- Content - Visual design - Readability - Language
Fundraising for Research
Ethical Review
Research Conduct & Operations
High expertise in disease area required
Trial Steering Committee
- Protocol follow up - Improving access - Adherence
Information to Trial Participants
- Protocol amendments - New safety information
Investigators Meeting
- Trial design - Recruitment
- Challenges - Opportunities can trigger amendments
Data Safety Monitoring Committee
- Benefit/Risk
- Drop-out issues - Amendments
Medium expertise in disease area required
Study Reporting
- Summary of interim results
- Dissemination in patient community
Dissemination, Communication, Post-Approval
High expertise in disease area required
Regulatory Affairs
- MAA Evaluation - EPAR Summaries - Lay summary of results
- Package leaflets - Updated safety communication
Medium expertise in disease area required
Health Technology Assessment (HTA)
- Assessment of value - Patient-relevant outcomes - Patient priorities
Post-communication study
- Contribution to publications
- Dissemination of research results to patient community / professionals