new updates 2013

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Swati Sharma

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Feb 19, 2013, 10:29:13 AM2/19/13
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Haemovigilance Programme

 

Haemovigilance is a continuous process of data collection and analysis of transfusion-related adverse  reactions in order to investigate their causes and outcomes, and prevent their occurrence or recurrence.

Indian Pharmacopoeia Commission in collaboration with National Institute of Biologicals has  launched  a Biovigilance programme (BvPI) including Haemovigilance  across the country under its Pharmacovigilance Programme of India ( PvPI)   with following Terms of References 

 

1. To track Adverse Reactions/ Events and incidence associated with Biologicals, Blood transfusion and Blood product administration (Haemovigilance ) as well as tissue organ and cell therapy transplantation.

 

2. To help identify trends, recommend best practices and interventions required to improve patient care and safety, while reducing overall cost of the healthcare system.

 

Haemovigilance Programme was launched on 10th Dec 2012 in already enrolled 60 Medical College under PvPI as an integral part of Pharmacovigilance Programme of India NIB is the Coordinating Centre, for BvPI to collate & analyze data with respect to Biologicals & Haemovigilance

  

A Core Group & Advisory Committee in this regard have already been constituted and first meeting of advisory committee was held on 29th Nov, 2012 to finalize Haemovigilance Transfusion Reaction Reporting Form (TRRF) & Guidance Document. The committee also discussed the modalities & roadmap for implementation of other Terms of References.

System of Pre-screening for submission of reports of SAEs to CDSCO.pdf
CHECKLIST FOR SUBMISSION 192013.pdf
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