Niels Westergaard, PhD, DScBiopeopleUniversity of CopenhagenDenmarkBuilding Knowledge & Competences for Patients’Involveme...
Why patient involvementIndustryDoctorsPatientsParadigm shiftTodayAre largely unaware about:• Clinical trials• Translationa...
The EUPATI Paradigm Getting the right information to the right people at the right time andin a useful format is just as ...
Audiences: advocacy leadersand the public at largeEUPATI Certificate Training Programme Academic Modular Certificate Prog...
EUPATI Certificate Programme Syllabus(Audience 1) The syllabus for the EUPATI certificate programme is divided into 6dist...
EUPATI Certificate Programme Syllabus(Audience 1)Discovery of Medicines & Planningof Medicines DevelopmentExploratory and ...
Syllabus examples (Audience 1)Phases of clinicaldevelopment: “Exploratory”and “Confirmatory” clinicaldevelopment versus “P...
Syllabus examples (Audience 1)Investigator Brochure:content, review andmaintenanceUnderstand the purpose of theclinical in...
EUPATI Toolbox Topics (Audience 2) The EUPATI Toolbox will take the form of an online resource centrethat will provide co...
EUPATI Toolbox Topics;(Audience 2)Discovery of Medicines & Planningof Medicines DevelopmentExploratory and ConfirmatoryCli...
Syllabus examples (Audience 2)Investigator Brochure:content, review andmaintenanceCritical review of clinical studyreport,...
What are we creating?EUPATI Certificate Training Programmee-learningClassroom style face to face teachingEnglishEUPATI ...
EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involvement in Medicines R&D, “Bring to life with E...
Upcoming SlideShare
Loading in …5
×

EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involvement in Medicines R&D, “Bring to life with EUPATI examples”

656 views
573 views

Published on

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

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
656
On SlideShare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
4
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involvement in Medicines R&D, “Bring to life with EUPATI examples”

  1. 1. Niels Westergaard, PhD, DScBiopeopleUniversity of CopenhagenDenmarkBuilding Knowledge & Competences for Patients’Involvement in Medicines R&DThe project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, resources of which are composedof financial contribution from the European Unions Seventh Framework Programme (FP7/2007-2013) and EFPIA companies.“Bring to life with EUPATI examples”
  2. 2. Why patient involvementIndustryDoctorsPatientsParadigm shiftTodayAre largely unaware about:• Clinical trials• Translational research• Personalized medicine• Pharmacoeconomics• Their potential supportive roles inthose areasEUPATI Vision for 2020Educate patients to be active in theDrug Development process –• Participation in clinical trials• Protocol design• Informed consent• Ethical review process,• Marketing authorization,• Value assessment• Healthcare policy• OthersShared goal:Getting the righttreatment to theright patients
  3. 3. The EUPATI Paradigm Getting the right information to the right people at the right time andin a useful format is just as important as developing the informationin the first placeDiligent ApproachIterative ProcessRight informationUseful formatRight PeopleRight timeTools:• Resource Review• Focus Groups across EU• EUPATI Nat. Platforms/• National Liaison TeamsAdvisors:• Regulatory Advisory Panel• Project Advisory Board• Ethics PanelUnique Product
  4. 4. Audiences: advocacy leadersand the public at largeEUPATI Certificate Training Programme Academic Modular Certificate Programme Patient Ambassadors in committees, R&D teams, … Patient Journalists raising awareness Patient Trainers for patient communities & networks100patientadvocates12.000patientadvocates100.000individualsEUPATI 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 ofthe development process of medicines for patients withlow (health) literacy. Wiki, YouTube, films and/or cartoons
  5. 5. EUPATI Certificate Programme Syllabus(Audience 1) The syllabus for the EUPATI certificate programme is divided into 6distinct modules covering the complete process of medicinesdevelopment. Within each sub-topic, learning outcomes indicate what students willlearn by completing the lessons. Throughout the blended learning offering students should becomefamiliar with the language used by the different stakeholdersinvolved in medicines development, and be able to understand therelevance of guidelines set by the regulatory authorities.
  6. 6. EUPATI Certificate Programme Syllabus(Audience 1)Discovery of Medicines & Planningof Medicines DevelopmentExploratory and ConfirmatoryClinical DevelopmentRegulatory Affairs, Medicinalproduct Safety, Pharmacovigilanceand Pharmaco-epidemiologyNon-Clinical Testing andPharmaceutical DevelopmentClinical TrialsHTA and the economics ofhealthcare6 Modules and 133 Topics
  7. 7. Syllabus examples (Audience 1)Phases of clinicaldevelopment: “Exploratory”and “Confirmatory” clinicaldevelopment versus “PhasesI-IV of clinical development”.Describe the process of medicinedevelopment and identify criticalfactors and decisions pointsApplicability ofpharmacokinetics to dosageregimen and study designOutline the basic principles ofpharmakokinetics and theirapplication to dose finding.Applicability of such principles insubsequent phases of drugdevelopmentTopic3.1–3.143.13.8Learning outcomesExploratory and ConfirmatoryClinical Development
  8. 8. Syllabus examples (Audience 1)Investigator Brochure:content, review andmaintenanceUnderstand the purpose of theclinical investigator brochureExplain and demonstrate theoverall approval process ......Critical review of clinical studyreport, publications andcommunications of studyresults to patientsRecognise the purpose of clinicalstudy reports and publicationsCritically analyse thecommunication of study results topatientsState the purpose andemployment of different means toreport patient outcomes (includingways in which patientient/PO canget involvedTopic4.1-4.374.14.35Learning outcomesClinical Trials
  9. 9. EUPATI Toolbox Topics (Audience 2) The EUPATI Toolbox will take the form of an online resource centrethat will provide comprehensive information on more than 100 differentsub-topics of the medicines development process. Users will be able to view material online and also download it for theirown use as is, or as parts of their own work.
  10. 10. EUPATI Toolbox Topics;(Audience 2)Discovery of Medicines & Planningof Medicines DevelopmentExploratory and ConfirmatoryClinical DevelopmentRegulatory Affairs, Medicinalproduct Safety, Pharmacovigilanceand Pharmaco-epidemiologyNon-Clinical Testing andPharmaceutical DevelopmentClinical TrialsHTA and the economics ofhealthcareSame principle as for Audience 1
  11. 11. Syllabus examples (Audience 2)Investigator Brochure:content, review andmaintenanceCritical review of clinical studyreport, publications andcommunications of studyresults to patientsTopic4.1-4.374.14.35No learning outcomesClinical Trials
  12. 12. What are we creating?EUPATI Certificate Training Programmee-learningClassroom style face to face teachingEnglishEUPATI Educational ToolboxRepository:- video, webcast, pdf, presentation, ebook, print readymaterial (booklets, pamphlets, etc), audioEnglish, French, German, Spanish, Polish, Russian, ItalianEUPATI Certificate Training ProgrammeWebPagesStreamed mediaEnglish, French, German, Spanish, Polish, Russian, Italian

×