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”
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EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involvement in Medicines R&D, “Bring to life with EUPATI examples”
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
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Niels Westergaard, PhD, DScBiopeopleUniversity of CopenhagenDenmark
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”
Why patient involvement
Industry
Doctors
PatientsParadigm shift
TodayAre largely unaware about: • Clinical trials• Translational research• Personalized medicine• Pharmacoeconomics • Their potential supportive roles in
those areas
EUPATI Vision for 2020Educate 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
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 informationUseful format
Right PeopleRight time
Tools:• Resource Review• Focus Groups across EU• EUPATI Nat. Platforms/• National Liaison Teams
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.
Non-Clinical Testing and Pharmaceutical Development
Clinical Trials
HTA and the economics of healthcare
6 Modules and 133 Topics
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
Topic 3.1 – 3.14
3.1
3.8
Learning outcomes
Exploratory and Confirmatory Clinical Development
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
Topic 4.1 - 4.37
4.1
4.35
Learning outcomesClinical Trials
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.
EUPATI Toolbox Topics; (Audience 2)
Discovery of Medicines & Planning of Medicines Development