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Under the administrative direction of the Heads of field offices and the technical guidance of the SBC Specialist for Immunization, the incumbent will provide support to the Ministry of Health on the development of systematic, planned and evidence-based and theory driven SBC strategies aiming at increasing sustainable demand and uptake of essential...
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For more information, please find the United Nations Global Marketplace (UNGM) link here: https://www.ungm.org/Public/Notice/190386

Objective of the RFP
The purpose of this Request for Proposals (RFP) is to enter into a contractual agreement with a
successful bidder and select a suitable Contractor to carry out the following work: Vaccines &
Immunization Devices IMD Assessment Team(VAX) technical assistance.

WHO is an Organization that is dependent on the budgetary and extra-budgetary contributions it
receives for the implementation of its activities. Bidders are, therefore, requested to propose the best and most cost-effective solution to meet WHO requirements, while ensuring a high level of service.

Description of Office/Region or Division/Service/Unit
The objective of the WHO Department of Regulation and Prequalification (RPQ) is to contribute to saving lives and improving health by developing global guidance and by collaborating with countries to provide:

1) equity of access to essential medicines and health products,
2) rational use of medicines and health products,
3) medicines and health products quality, safety and efficacy/performance.

The Prequalification Team (PQT), within the RPQ department, promotes and facilitates access to safe and appropriate diagnostics/medical devices, medicines and vaccines of assured quality through advocacy and policy, prequalification, quality assurance systems and strengthening national regulatory and laboratory programmes. PQT's global activities aim at ensuring health products are accessible, available at reasonable cost, used appropriately and are provided within an adequate regulatory framework and a sustainable health care system.

Embed within the vaccine (VAX) PQ team the immunization devices (IMD) team is the global norms and standards setter for the quality, safety, performance and suitability of all immunization equipment devices for LMICs from vaccine vial level temperature monitor throughout the cold chain through to the disposable of the used prequalified syringe in a prequalified safety box . The IMD specifies and prequalifies all the equipment and devices required for the transport, storage, monitoring and delivery of vaccine.

Characteristics of the Contractor

The Contractor shall be a for profit or not for profit institution operating in the field of Immunisation
equipment and devices.

An accreditation (ISO 9001 or equivalent; other in a relevant field or specific
accreditation/certification) or an on-going accreditation process by a certified accreditation body
would be an asset (desirable).

Previous experience

Proven experience in the field of :
o Multi-country LMIC EPI IMD experience
o Immunization equipment and device experience
• .Previous work with WHO, or Country EPI programmes, or other international organizations
and/or major institutions in the field of immunization equipment and devices ;

• Experience in:
o WHO IMD standards
o Mechanical engineering capability
o IMD equipment testing capabilities and experience including a thermal chamber
o LMIC in-country experience

The selected contractor is expected to dedicate the following human resources to the project:
• A project manager of an adequate level of qualification and experience (please attach resume
to your proposal) shall be dedicated to the project.
• The designated project manager that should be the same all along implementation, including
consideration in contingency plans in case the focal point is absent.
• Sufficient capacity and knowledge is required to cover the following areas of expertise:
o Adequate technical knowledge to author IMD standards.
o Adequate technical knowledge to assess cold chain equipment PQ dossier
o Adequate technical knowledge to provide expert technical advice on cold chain
equipment issues
o Adequate technical knowledge to support ODK-X devilment for IMD PMM activities
o Adequate technical knowledge to lab and field test cold chain equipment.

• WHO pays utmost attention to the level of qualification and experience of the individuals
involved, and to continuity in the services. The profiles (no individual names required) of the
personnel proposed for these services should be included in the technical proposal.
• All staff with full professional working proficiency/native or bilingual proficiency in English
The bidder is expected to outline the roles and responsibilities of those staff in the technical proposal.
Activities will be carried in normal working hours of CET time zone.

Work to be performed
The Objective of this work is for the supplier to support the mandate of the VAX PQ IMD team to
ensure access for members States to programmatically suitable safe quality immunization equipment and devices. The general objectives are to provide technical assistance in the form of IMD standards authorship and review, product bench and field testing, and PQ dossier application reviews.

Key requirements

PQ application reviews
Provide technical performance reviews of prequalification dossier submissions (approximately 30 per annum)for, Vaccine fridges and freezers, vaccine carriers and old boxes, coolant packs, temperature monitoring device, cold chain accessories, and injections devices

Standard authorship
Author and review IMD technical standards and guidance documents including specifications
and verification protocols creation and revisions (approximately 10 per annum).

Technical Advice
1. Provide advice on ad-hoc technical issues across all IMD PQ categories as they arise
(approximately 40 per annum).
2. Support industry technical calls and consultations (approximately 12 per annum).

Lab testing
Carry out IMD CCE and injection device testing for concept design, new materials and as
part of PMM identified performance/quality issue (approximately 4 per annum)..

IMD working group
1. Attend, present and input to IMD WG calls and meetings (4 standing full WG meeting
including two 3 day f2f per annum and two TCs and approx. 10 ad hoc core WG meeting)..
2. Attend, present and input to IMD industry consultations.

Field Studies
1. Review new IMD equipment category/sub-category mandatory field study protocols
(approximately 4 per annum)..
2. Run in-country IMD equipment and new IMD equipment category/sub-category studies
(approximately 2 per annum)..

Post Market Monitoring PMM
1. Provide technical IT support to the IMD PMM programme; specially to support the creation
and evolution of the ODK-X data database to manage country ODK-X PMM data and to
expand the system to be able to manage other PMM data sources as they become available,
such as the VERO app and RTMD data streams.
2. Support the cleaning of country inventory data and provide PMM data analysis to support
country feedback (approximately 5 countries and 5 NGO in 2023 )..

QMS activities
1. Review manufacturer CAPA plans following quality issues (approximately 3 per annum
expecting to rise as QMS improves )..
2. Support manufacturer site audits (QMS and testing quality/capacity review)
(approximately 3 in person 4day inspections per annum)..
Support WHO accredited laboratory site audits (QMS and testing quality/capacity
review) (approximately 4 remote per annum)..

Injection device PQ technical assistance
1. Update and create new injection device prequalification manufacturers guide and detailed
dossier submission guide with accompanying tools, including trackability matrix.
2. Updated WHO PQ injection device review templates (for Auto-disable syringes E008 and
E0113 RUP).
3. Support Manufacturer PQ injection two day f2f device informational meeting Geneva
planned for Q3 2023. Prepare presentations and leaning material to cover, requirements of
ISO 7886-3 and 4, WHO dossier submission requirements, good documentation practice,
4. Development of SOP’s and test fixtures for laboratory based syringe testing for validation of
manufacturer test data as warranted for critical requirements of ISO 7866-3 ands 4.
5. Development of desk top physical sample inspection procedures for dossier product
6. On-boarding curriculum/process guideline document for technical dossier reviewers.
7. Support Online dossier submission process development (continuing previous work done by
WHO). Review the IT solution once it is provided to the technical unit.

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