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Consultation to support the work on collecting and analysing safety data associated... Tender

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WHO has floated a tender for Consultation to support the work on collecting and analysing safety data associated with dolutegravir. The project location is Switzerland and the tender is closing on 10 Aug 2018. The tender notice number is 2018/CDS/HIV/009, while the TOT Ref Number is 25562050. Bidders can have further information about the Tender and can request the complete Tender document by Registering on the site.

Procurement Summary

Country : Switzerland

Summary : Consultation to support the work on collecting and analysing safety data associated with dolutegravir

Deadline : 10 Aug 2018

Other Information

Notice Type : Tender

TOT Ref.No.: 25562050

Document Ref. No. : 2018/CDS/HIV/009

Competition : ICB

Financier : United Nations Secretariat

Purchaser Ownership : -

Tender Value : Refer Document

Purchaser's Detail

Purchaser : WHO
Email: pdifin@who.int
First name: J
Surname: Peron
Telephone country code: Switzerland (+41)
Telephone number: 0
Switzerland
Email :pdifin@who.int

Tender Details

Tender are invited for Consultation to support the work on collecting and analysing safety data associated with dolutegravir

Deadline : 10-Aug-2018 17:00 (GMT 2.00)

Published : 03-Aug-2018

Type of Notice : Request for proposal

Beneficiary Country/Territory : Switzerland

Reference : 2018/CDS/HIV/009

Description : On 18 May 2018, WHO has issued a statement signalling a potential risk of neural tube defects in infants born to women who were taking dolutegravir (DTG) at the time of conception. WHO is working with all stakeholders to gather and review safety data about women who have become pregnant while taking DTG worldwide to determine if this risk is confirmed. There is a need to collect any existing and new data from various partners including from pharmacovigilance databases (FDA, EMA, WHO, others), from on-going cohorts, research and clinical trials, and assess the potential risk of teratogenicity and pregnancy adverse outcomes of dolutegravir as well as a potential effect across the integrase strand inhibitor (INSTI) antiretroviral drug class. The review will address the signal of a potential risk of neural tube defects and any other safety issues relative to the use of DTG and/or other INSTIs during the peri-conception period and 1st trimester or later during pregnancy.

The HIV Department seeks technical support to work on these varied areas. The consultant will provide support to the collection and review of safety data, and present progress and findings to the WHO sub-committee on safety of dolutegravir to regularly report on the safety signal of potential risk of neural tube defects to WHO Advisory Committee on Safety of Medical Products (ACSoMP) and WHO ART Guidelines Development Group.

The contractor will assist WHO/HIV/SIP with Technical expertise for WHO's wor...