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Getting started!

In this very short course, you will get started with an overview of medicines research and development.

(1 Course)

Introduction to Medicines R&D

In this introductory section, you will acquire the basic skills and knowledge about medicines research and ...
(6 Courses)

Non-clinical Development

The courses of this section will explain non-clinical studies in detail, the concepts of pharmacogenetics/g...

(3 Courses)

Clinical Development

This section contains courses on clinical development and trials, including statistics, ethics, the role of...

(7 Courses)

Health Technology Assessment (HTA)

The purpose of this module is to introduce you to health technology assessment (HTA). In these courses you ...
(5 Courses)

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
Research Design & Planning
Research Conduct & Operations
Dissemination, Communication, Post-Approval

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