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PATIENT INVOLVEMENT IN EMA AND CONFLICT OF INTEREST
Athanasiou Dimitrios
World Duchenne Organization Board Member
PDCO MEMBER EUROPEAN MEDICINES AGENCY
MDA Hellas
© 2018 WDO. All rights reserved.
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter.
These PowerPoint slides are the intellectual property of the individual presenter and with all rights reserved.
WDO logos are registered trademarks. All other trademarks are the property of their respective owners.
DISCLAIMER
DISCLOSURES
I have no real or apparent relevant financial relationships to disclose
DOI
www.ema.europa.eu/docs/en_GB/document_library/contacts/athanasioud_DI.pdf
PATIENT INVOLVEMENT IN EMA
Do you have the proper DOI?
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000178.jsp
DECLARATION OF INTERESTS AND THE CONFIDENTIALITY UNDERTAKING
THE LAW : ALL EXPERTS NEED TO DEMONSTRATE THEIR INDEPENDENCE AND IMPARTIALITY.
2.1 EMPLOYMENT
2.2 CONSULTANCY
2.3 STRATEGIC ADVISORY ROLE
2.4 FINANCIAL INTERESTS
2.5 PRINCIPAL INVESTIGATOR
2.6 INVESTIGATOR
2.7 GRANT / FUNDING TO ORGANIZATION / INSTITUTION
2.8 CLOSE FAMILY MEMBER INTEREST
2.9 ANY OTHER INTERESTS OR FACTS
Do you have the proper DOI?
Quick heads-up ! Protect your DOI !
2.2 CONSULTANCY
CONSULTANCY MEANS PROVISION OF ADVICE (INCLUDING TRAINING ON A ONE TO ONE BASIS) TO A
PHARMACEUTICAL COMPANY REGARDLESS OF CONTRACTUAL ARRANGEMENTS OR ANY FORM OF
REMUNERATION.
CONSULTANCY IS CONSIDERED ANY OCCASION THAT YOU ENGAGE WITH A PHARMACEUTICAL
COMPANY REGARDLESS OF THE SUBJECT.
THIS DOES NOT INCLUDE PARTICIPATION IN PUBLIC MEETINGS SUCH AS CONFERENCES
.
Do you have the proper DOI?
2.3 STRATEGIC ADVISORY ROLE
STRATEGIC ADVISORY ROLE MEANS PARTICIPATION (WITH A RIGHT TO VOTE ON/INFLUENCE THE
OUTPUTS) IN A(N) (SCIENTIFIC) ADVISORY BOARD/STEERING COMMITTEE WITH THE ROLE OF
PROVIDING ADVICE/EXPRESSING OPINIONS ON THE (FUTURE) STRATEGY, DIRECTION OR
DEVELOPMENT ACTIVITIES OF A PHARMACEUTICAL COMPANY, EITHER IN TERMS OF GENERAL
STRATEGY OR PRODUCT RELATED STRATEGY, REGARDLESS OF CONTRACTUAL ARRANGEMENTS
OR ANY FORM OF REMUNERATION.
.
Do you have the proper DOI?
2.7 GRANT / FUNDING TO ORGANIZATION
GRANT OR OTHER FUNDING TO AN ORGANISATION MEANS ANY CURRENT FUNDING RECEIVED
FROM A PHARMACEUTICAL COMPANY BY AN ORGANISATION TO WHICH YOU BELONG, OR FOR
WHICH YOU PERFORM ANY KIND OF ACTIVITY, AND WHICH IS USED TO SUPPORT ANY OF YOUR
ACTIVITIES WHETHER OR NOT THEY ARE RELATED TO RESEARCH WORK.
Do you have the proper DOI?
THE DEVIL IS ALWAYS HIDDEN IN THE DETAILS
• DO NOT DISCLOSE
• DO NOT INTERACT WITH THE SPONSOR BEFORE OF AFTER
• MAKE SURE THAT YOU DOI (Declaration of Interest) IS UPDATED
• MAKE SURE THAT YOU DO NOT HAVE CONFLICT OF INTEREST
EXAMPLES
• In dought ? ASK
Dimitrios Athanasiou,
dathax@gmail.com
THANK YOU!!!!

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patient involvement in ema - conflict of interest.da

  • 1. PATIENT INVOLVEMENT IN EMA AND CONFLICT OF INTEREST Athanasiou Dimitrios World Duchenne Organization Board Member PDCO MEMBER EUROPEAN MEDICINES AGENCY MDA Hellas © 2018 WDO. All rights reserved.
  • 2. The views and opinions expressed in the following PowerPoint slides are those of the individual presenter. These PowerPoint slides are the intellectual property of the individual presenter and with all rights reserved. WDO logos are registered trademarks. All other trademarks are the property of their respective owners. DISCLAIMER DISCLOSURES I have no real or apparent relevant financial relationships to disclose DOI www.ema.europa.eu/docs/en_GB/document_library/contacts/athanasioud_DI.pdf
  • 3. PATIENT INVOLVEMENT IN EMA Do you have the proper DOI? http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000178.jsp
  • 4.
  • 5. DECLARATION OF INTERESTS AND THE CONFIDENTIALITY UNDERTAKING THE LAW : ALL EXPERTS NEED TO DEMONSTRATE THEIR INDEPENDENCE AND IMPARTIALITY. 2.1 EMPLOYMENT 2.2 CONSULTANCY 2.3 STRATEGIC ADVISORY ROLE 2.4 FINANCIAL INTERESTS 2.5 PRINCIPAL INVESTIGATOR 2.6 INVESTIGATOR 2.7 GRANT / FUNDING TO ORGANIZATION / INSTITUTION 2.8 CLOSE FAMILY MEMBER INTEREST 2.9 ANY OTHER INTERESTS OR FACTS Do you have the proper DOI? Quick heads-up ! Protect your DOI !
  • 6. 2.2 CONSULTANCY CONSULTANCY MEANS PROVISION OF ADVICE (INCLUDING TRAINING ON A ONE TO ONE BASIS) TO A PHARMACEUTICAL COMPANY REGARDLESS OF CONTRACTUAL ARRANGEMENTS OR ANY FORM OF REMUNERATION. CONSULTANCY IS CONSIDERED ANY OCCASION THAT YOU ENGAGE WITH A PHARMACEUTICAL COMPANY REGARDLESS OF THE SUBJECT. THIS DOES NOT INCLUDE PARTICIPATION IN PUBLIC MEETINGS SUCH AS CONFERENCES . Do you have the proper DOI?
  • 7. 2.3 STRATEGIC ADVISORY ROLE STRATEGIC ADVISORY ROLE MEANS PARTICIPATION (WITH A RIGHT TO VOTE ON/INFLUENCE THE OUTPUTS) IN A(N) (SCIENTIFIC) ADVISORY BOARD/STEERING COMMITTEE WITH THE ROLE OF PROVIDING ADVICE/EXPRESSING OPINIONS ON THE (FUTURE) STRATEGY, DIRECTION OR DEVELOPMENT ACTIVITIES OF A PHARMACEUTICAL COMPANY, EITHER IN TERMS OF GENERAL STRATEGY OR PRODUCT RELATED STRATEGY, REGARDLESS OF CONTRACTUAL ARRANGEMENTS OR ANY FORM OF REMUNERATION. . Do you have the proper DOI?
  • 8. 2.7 GRANT / FUNDING TO ORGANIZATION GRANT OR OTHER FUNDING TO AN ORGANISATION MEANS ANY CURRENT FUNDING RECEIVED FROM A PHARMACEUTICAL COMPANY BY AN ORGANISATION TO WHICH YOU BELONG, OR FOR WHICH YOU PERFORM ANY KIND OF ACTIVITY, AND WHICH IS USED TO SUPPORT ANY OF YOUR ACTIVITIES WHETHER OR NOT THEY ARE RELATED TO RESEARCH WORK. Do you have the proper DOI?
  • 9.
  • 10. THE DEVIL IS ALWAYS HIDDEN IN THE DETAILS • DO NOT DISCLOSE • DO NOT INTERACT WITH THE SPONSOR BEFORE OF AFTER • MAKE SURE THAT YOU DOI (Declaration of Interest) IS UPDATED • MAKE SURE THAT YOU DO NOT HAVE CONFLICT OF INTEREST