PROJECT NOTIFY
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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

  • PROJECT NOTIFY

Sharing vigilance experience and knowledge globally

- the NOTIFY Project (WHO)


Project not i f y the google site

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

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)


The bologna meeting participants

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)


Working groups 1 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


Project notify

An example of a worksheet .... (HPCs)

Over 1,700 references in total – Endnote Library


The development of v s didactic guidance

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


The development of v s didactic guidance1

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


Project notify

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


The development of v s didactic guidance2

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


The development of v s didactic guidance3

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


Working groups 6 10

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


An example of a master worksheet

An example of a master worksheet...


The development of notify v s guidance

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


Project notify

www.notifylibrary.org


Project notify

Ove 1800 references describing adverse outcomes in transplantation and assisted reproduction


Project notify

A sample of the bibiography


Project notify

  • 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


Project notify

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


Project notify

Clicking on a single reference


Other notify outputs

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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