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PROJECT NOTIFY

PROJECT NOTIFY. Sharing vigilance experience and knowledge globally - the NOTIFY Project (WHO). PROJECT NOT I F Y: The Google Site. 10 global working groups led by international experts Co-ordinated by D Michael Strong. Definitions – EU and NOTIFY.

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PROJECT NOTIFY

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  1. PROJECT NOTIFY Sharing vigilance experience and knowledge globally - the NOTIFY Project (WHO)

  2. PROJECT NOT I F Y:The Google Site 10 global working groups led by international experts Co-ordinated by D Michael Strong

  3. Definitions – EU and NOTIFY EU: ‘Serious Adverse Reaction (SAR)’ means an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity (NOTIFY: An adverse response that HAS occurred, including a communicable disease, in a recipient or in a living donor) EU: ‘Serious Adverse Event (SAE)’ means any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity (NOTIFY: An adverse occurrence that MIGHT lead to harm in a recipient or a living donor)

  4. The Bologna Meeting Participants • 116 attendees • Regulators, government agencies, professional societies, international organisations, scientific and clinical experts in organ, tissue and cell transplantation and in assisted reproduction. • 36 countries (Bulgaria, Italy, USA, Switzerland, Spain, France, Germany, Netherlands, Japan, India, Argentina, Portugal, Ireland, Denmark, Czech Republic, Lithuania, Slovenia, Australia, Brazil, Norway, Slovakia, Luxembourg, Thailand, Canada, Poland, Belgium, Singapore, Austria, Iran, South Africa, Russia, Croatia, Cyprus, Malta, Romania, Nigeria)

  5. Working Groups 1-5 Groups 1-5 gathered documented cases of adverse reactions and events associated with organ, tissue or cell application in humans (with references), identifying the triggers that alerted clinicians and the procedures followed to clarify imputability

  6. An example of a worksheet .... (HPCs) Over 1,700 references in total – Endnote Library

  7. The Development of V&S Didactic Guidance Group 1 List Reactions and Events in Organs Group 2 Lists Reactions and Events for Tissues (non ocular) Group 3 Lists Reactions and Events for HSC Group 4 Lists Reactions and Events for Ocular Tissues Group 5 Lists Reactions and Events for Gametes and Embryos Group 6 Master Sheet Infections Group 7 Master Sheet Malignancy Group 8 Master Sheet Characteristics and Handling Group 9 Master Sheet Clinical Practice Group 10 Master Sheet Genetic and Donor

  8. The Development of V&S Didactic Guidance Group 1 List Reactions and Events in Organs Group 2 Lists Reactions and Events for Tissues (non ocular) Group 3 Lists Reactions and Events for HSC Group 4 Lists Reactions and Events for Ocular Tissues Group 5 Lists Reactions and Events for Gametes and Embryos Group 6 Master Sheet Infections Group 7 Master Sheet Malignancy Group 8 Master Sheet Characteristics and Handling Group 9 Master Sheet Clinical Practice Group 10 Master Sheet Genetic and Donor

  9. The Development of V&S Didactic Guidance Group 1 List Reactions and Events in Organs Group 2 Lists Reactions and Events for Tissues (non ocular) Group 3 Lists Reactions and Events for HSC Group 4 Lists Reactions and Events for Ocular Tissues Group 5 Lists Reactions and Events for Gametes and Embryos Group 6 Master Sheet Infections Group 7 Master Sheet Malignancy Group 8 Master Sheet Characteristics and Handling Group 9 Master Sheet Clinical Practice Group 10 Master Sheet Genetic and Donor

  10. The Development of V&S Didactic Guidance Group 1 List Reactions and Events in Organs Group 2 Lists Reactions and Events for Tissues (non ocular) Group 3 Lists Reactions and Events for HSC Group 4 Lists Reactions and Events for Ocular Tissues Group 5 Lists Reactions and Events for Gametes and Embryos Group 6 Master Sheet Infections Group 7 Master Sheet Malignancy Group 8 Master Sheet Characteristics and Handling Group 9 Master Sheet Clinical Practice Group 10 Master Sheet Genetic and Donor

  11. The Development of V&S Didactic Guidance Group 1 List Reactions and Events in Organs Group 2 Lists Reactions and Events for Tissues (non ocular) Group 3 Lists Reactions and Events for HSC Group 4 Lists Reactions and Events for Ocular Tissues Group 5 Lists Reactions and Events for Gametes and Embryos Group 6 Master Sheet Infections Group 7 Master Sheet Malignancy Group 8 Master Sheet Characteristics and Handling Group 9 Master Sheet Clinical Practice Group 10 Master Sheet Genetic and Donor

  12. Working Groups 6-10 Groups 6-10 regrouped the cases collected by groups 1-5 by type of reaction/event and developed guidance for clinicians for early detection and treatment and for establishing cause

  13. An example of a master worksheet...

  14. The Development of Notify V&S Guidance Group 1 List Reactions and Events in Organs Group 2 Lists Reactions and Events for Tissues (non ocular) Group 3 Lists Reactions and Events for HSC Group 4 Lists Reactions and Events for Ocular Tissues Group 5 Lists Reactions and Events for Gametes and Embryos Group 6 Master Sheet Infections Group 7 Master Sheet Malignancy Group 8 Master Sheet Characteristics and Handling Group 9 Master Sheet Clinical Practice Errors Group 10 Master Sheet Genetic and Donor • 5 DIDACTIC GUIDANCE DOCUMENTS published together with the bologna meeting report

  15. www.notifylibrary.org

  16. Ove 1800 references describing adverse outcomes in transplantation and assisted reproduction

  17. A sample of the bibiography

  18. Search by substance type : • all organs, • a specific organ, • all tissues, • a specific tissue • etc. • or by incident type : • all reactions, • reactions involving infection, • reactions involving malignancy • etc. • or using key words or phrases: Analysis provided by international expert groups

  19. .pdf for printing/saving of a search result with one record per page

  20. Clicking on a single reference

  21. Other Notify Outputs • A WHO Booklet on Vigilance and Surveillance in draft • A global network of vigilance experts discussing terminology, reviewing cases and developing guidance

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