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title	Serious

(

Product

)

Events and Adverse Reactions

: S(P)EARThe

- SPEAR

WMDA has set up a central global reporting system

for WMDA member organisations

to report Serious (Product) Events and Adverse Reactions – S(P)EARs – to the WMDA.

To access the reporting system, you login with your email address and password. If you do not have a password

yet

,

please check with

contact the WMDA office

whether you are registered S(P)EAR reporter

.

Aim

To gain insight in the occurrence of serious events and adverse effects in relation to blood stem cell donation by unrelated donors and blood stem cell collection/processing from unrelated donors.

Purpose

To collect and analyse information on recipient and donor serious adverse events (SAE) and reactions which affect donors and/or products from all WMDA stem cell donor registries and cord blood banks.
To follow a rapid alert system for disseminating information on SAE/R to all members of the international community in contact with allogeneic donors and patients.

Warning

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false

title	Important note

!

on Rapid Alerts

The

S(P)EAR

SPEAR Committee reviews all reported incidents once a week. If you have a rapid alert that needs to be shared with the community quickly, we urge you to

send a separate

submit it via the online reporting tool and to immediately send an e-mail to

the WMDA office (

sear-spear@wmda.info

) or

or call us on: +31 88 505 7900.

In case of recall or big risks for future donations or transfusions a report can be submitted as a rapid alert.

This includes, but is not limited to:

any prohibition or restriction imposed by the competent authority/health authorities of any country in which the stem cell product is provided or transplanted;
donor death;