EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involvement in Medicines R&D, “Bring to life with EUPATI examples”, by Niels Westergaard, PhD, DSc Biopeople, University of Copenhagen, Denmark

1. Niels Westergaard, PhD, DSc
Biopeople
University of Copenhagen
Denmark
Building Knowledge & Competences for Patients’
Involvement in Medicines R&D
The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, resources of which are composed
of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies.
“Bring to life with EUPATI examples”

2. Why patient involvement
Industry
Doctors
Patients
Paradigm shift
Today
Are largely unaware about:
• Clinical trials
• Translational research
• Personalized medicine
• Pharmacoeconomics
• Their potential supportive roles in
those areas
EUPATI Vision for 2020
Educate patients to be active in the
Drug Development process –
• Participation in clinical trials
• Protocol design
• Informed consent
• Ethical review process,
• Marketing authorization,
• Value assessment
• Healthcare policy
• Others
Shared goal:
Getting the right
treatment to the
right patients

3. The EUPATI Paradigm
 Getting the right information to the right people at the right time and
in a useful format is just as important as developing the information
in the first place
Diligent Approach
Iterative Process
Right information
Useful format
Right People
Right time
Tools:
• Resource Review
• Focus Groups across EU
• EUPATI Nat. Platforms/
• National Liaison Teams
Advisors:
• Regulatory Advisory Panel
• Project Advisory Board
• Ethics Panel
Unique Product

4. Audiences: advocacy leaders
and the public at large
EUPATI Certificate Training Programme
 Academic Modular Certificate Programme
 Patient Ambassadors in committees, R&D teams, …
 Patient Journalists raising awareness
 Patient Trainers for patient communities & networks
100
patient
advocates
12.000
patient
advocates
100.000
individuals
EUPATI Educational Toolbox
 Educational tools for patient advocates
 Variety of distributable formats: Paper-based booklets,
presentations, eLearning, webinars, videos etc.
EUPATI Internet Library
 Patients & lay public at large, e.g. on specific aspects of
the development process of medicines for patients with
low (health) literacy.
 Wiki, YouTube, films and/or cartoons

5. EUPATI Certificate Programme Syllabus
(Audience 1)
 The syllabus for the EUPATI certificate programme is divided into 6
distinct modules covering the complete process of medicines
development.
 Within each sub-topic, learning outcomes indicate what students will
learn by completing the lessons.
 Throughout the blended learning offering students should become
familiar with the language used by the different stakeholders
involved in medicines development, and be able to understand the
relevance of guidelines set by the regulatory authorities.

6. EUPATI Certificate Programme Syllabus
(Audience 1)
Discovery of Medicines & Planning
of Medicines Development
Exploratory and Confirmatory
Clinical Development
Regulatory Affairs, Medicinal
product Safety, Pharmacovigilance
and Pharmaco-epidemiology
Non-Clinical Testing and
Pharmaceutical Development
Clinical Trials
HTA and the economics of
healthcare
6 Modules and 133 Topics

7. Syllabus examples (Audience 1)
Phases of clinical
development: “Exploratory”
and “Confirmatory” clinical
development versus “Phases
I-IV of clinical development”.
Describe the process of medicine
development and identify critical
factors and decisions points
Applicability of
pharmacokinetics to dosage
regimen and study design
Outline the basic principles of
pharmakokinetics and their
application to dose finding.
Applicability of such principles in
subsequent phases of drug
development
Topic3.1–3.14
3.1
3.8
Learning outcomes
Exploratory and Confirmatory
Clinical Development

8. Syllabus examples (Audience 1)
Investigator Brochure:
content, review and
maintenance
Understand the purpose of the
clinical investigator brochure
Explain and demonstrate the
overall approval process ......
Critical review of clinical study
report, publications and
communications of study
results to patients
Recognise the purpose of clinical
study reports and publications
Critically analyse the
communication of study results to
patients
State the purpose and
employment of different means to
report patient outcomes (including
ways in which patientient/PO can
get involved
Topic4.1-4.37
4.1
4.35
Learning outcomes
Clinical Trials

9. EUPATI Toolbox Topics (Audience 2)
 The EUPATI Toolbox will take the form of an online resource centre
that will provide comprehensive information on more than 100 different
sub-topics of the medicines development process.
 Users will be able to view material online and also download it for their
own use as is, or as parts of their own work.

10. EUPATI Toolbox Topics;
(Audience 2)
Discovery of Medicines & Planning
of Medicines Development
Exploratory and Confirmatory
Clinical Development
Regulatory Affairs, Medicinal
product Safety, Pharmacovigilance
and Pharmaco-epidemiology
Non-Clinical Testing and
Pharmaceutical Development
Clinical Trials
HTA and the economics of
healthcare
Same principle as for Audience 1

11. Syllabus examples (Audience 2)
Investigator Brochure:
content, review and
maintenance
Critical review of clinical study
report, publications and
communications of study
results to patients
Topic4.1-4.37
4.1
4.35
No learning outcomes
Clinical Trials

12. What are we creating?
EUPATI Certificate Training Programme
e-learning
Classroom style face to face teaching
English
EUPATI Educational Toolbox
Repository:- video, webcast, pdf, presentation, ebook, print ready
material (booklets, pamphlets, etc), audio
English, French, German, Spanish, Polish, Russian, Italian
EUPATI Certificate Training Programme
WebPages
Streamed media
English, French, German, Spanish, Polish, Russian, Italian