CIOMS/WHO Working Group on Vaccine Pharmacovigilance
The report from the Working Group has recently been published in collaboration with WHO. The report covers the activities and outputs of the CIOMS/WHO Working Group on Vaccine Pharmacovigilance (2005-2010) and was published in its full version as a PDF file on the websites of CIOMS and WHO.
The Working Group was established in November 2005 at the request of WHO to:
The Working Group is currently composed of members from the pharmaceutical industry, regulatory agencies, governmental institutions, and academia both from industrialised and developing countries as well as from international organizations. The aim of the group is to complete a final document including all general definitions as well as the Introduction and Definition sections of all endorsed Brighton Collaboration definitions by the end of 2010, and then print it as a CIOMS publication.
Ten meetings have been held since the establishment of the Working Group:
The developed business plan and status as of April 2010 is as follows:
Published case definitions reviewed and endorsed by the WG
Six case definitions have already been published in English, Spanish and French on the Brighton Collaboration website:
New case definitions reviewed and endorsed by the WG
Comparability of SMQs and Brighton Collaboration (BC) case definitions
The MedDRA Maintenance and Support Services Organization (MSSO) performed a mapping between concepts in the published Brighton Collaboration vaccine adverse event definitions and terms in MedDRA Version 11.1 (September 2008). The following BC definitions were mapped:
During the mapping process, concepts in the case definitions that are not already part of MedDRA were identified. These findings made the WG decide to make a recommendation to the Brighton Secretariat that Brighton working groups consider MedDRA terms when developing new definitions CIOMS VIII Signal Detection Working Group
Comments regarding various Signal definitions were sent to CIOMS WG VIII. A vaccine-specific point-to-consider document as an annex to Signal definition in collaboration with CIOMS WG VIII has been finalized. WHO-UMC Working Group on vaccine identifiability
The WG recommended that a drug dictionary for vaccines is needed and supports the Uppsala Monitoring Centre (UMC; WHO Collaborating Center for International Drug Monitoring) in their efforts in this respect.
© 2013 CIOMS - All rights reserved