Roster of Consultants - In Vitro Diagnostics Assessment

Purpose of consultancy

To contribute to the development of technical reports, recommendations and assessment reports, for the following:

• Review of technical documentation for IVDs within the scope of prequalification (PQ);
• Review of technical documentation for change requests submitted for review;
• Benefit-risk profiles of IVDs as part of risk-based assessments;
• Development of Prequalification Technical Specifications Series (TSS) and Prequalification Technical Guidance Series (TGS); and
• any other technical reviews in the scope of the Team’s work.

Background

The Prequalification In Vitro Diagnostics assessment team coordinates three review mechanisms for in vitro diagnostics: prequalification, the expert review panel and the emergency use listing. The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (PQT/IVD) is a comprehensive quality assessment of individual In Vitro Diagnostics (IVD) through a standardized procedure aimed at determining whether the product meets the World Health Organization prequalification requirements. The expert review panel and the emergency use listing are risk-based assessments of in vitro diagnostics quality, safety and performance, aimed at addressing specific public health needs, including in a public health emergency. The Prequalification Unit (PQ) maintains a pool of experts that assist the IVD Assessment team with various tasks related to the product dossier component of the prequalification assessment. Experts must understand the regulatory requirements related to the dossier review, including the respective standards and internationally accepted guidance documents, the major regulatory harmonization initiatives and the associated guidance. The expert should have experience with IVD product dossier review and dossier-related guidance and specifications development. The Prequalification In Vitro Diagnostics assessment team continuously expands the scope of its work to new disease areas and product technologies and thus is in need of additional experts.

The IVD Assessment Team requires experts with a comprehensive knowledge of IVD and the challenges related to their use in resource-limited settings. A critical component of the assessment process relates to a technical review of the product dossier. To undertake this activity, external experts, with proven technical expertise, are utilised to conduct the product dossier review. As the WHO continues to expand the disease areas for prequalification assessment, Technical Specifications Series (TSS) documents must be developed to outline the minimum performance criteria to be submitted as part of the product dossier to meet prequalification requirements for new manufacturers. Subject matter experts with proven technical expertise are needed to draft Technical Specification Series documents for new or existing disease areas for public consultation, and to also to review of public comments in the finalization of the TSS publications.

The WHO Prequalification of In Vitro Diagnostics also undertakes emergency use listing assessment of commercially available IVD with emphasis on point-of-care nucleic-acid tests and antigen rapid diagnostic tests and their suitability for use in resource-limited settings. As the SARS-CoV-2 pandemic evolves, in this rapidly changing environment, WHO requires experts who keep abreast of the current state of knowledge relating to COVID-19, diagnostics, and quality issues as they become known in the public space, with a particular emphasis on use in resource limited settings, reflecting the needs of some WHO Member States.

In addition, the In Vitro Diagnostics Assessment Team coordinates an Expert Review Panel (ERP) mechanism to review the risks and benefits associated with procurement and use of IVD that may have a high public health impact, but that are neither prequalified nor have yet undergone stringent regulatory assessment by a founding member of the Global Harmonization Task Force (now the International Medical Device Regulators Forum). The Expert Review Panel is intended as an interim quality assurance measure, valid for a time-limited period, for IVD that will go on to complete a stringent review process. The mechanism can facilitate access to innovative diagnostic products for which the associated risks are deemed to be less than the potential benefits.

A process for reviewing changes related to products which have been prequalified or listed under the above-mentioned risk-based mechanisms is also in place to ensure an ongoing compliance with the requirements used to assess products.

The IVD assessment team has expanded the scope of work to include assessment of IVDs for Tuberculosis, glucose monitoring, haemoglobin point of care and neglected tropical diseases. Due to the new technical areas incorporated into the body of work conducted by the IVD assessment team, subject matter experts are needed

Deliverables

• Deliverable 1: Conduct reviews of technical documentation for In Vitro Diagnostics submitted for prequalification.
• Deliverable 2: Provide technical input on prequalification specifications and guidance documents.
• Deliverable 3: Conduct risk-benefit reviews.
• Deliverable 4: Conduct reviews of technical documentation for change requests.
• Deliverable 5: Review technical information within the expanded scope of the In vitro diagnostics assessment team and provide a report outlining key findings.

Qualifications, experience, skills and languages

Educational Qualifications

Essential: Advanced University Degree in Health Sciences or related medical/scientific field.

Desirable: PhD degree in biology, microbiology or other medical science.

Experience

Essential:

• Over 10 years’ experience working in research, development and/or manufacturing of in vitro diagnostic medical devices and/or implementation of diagnostic testing for public health.
• Experience with in vitro diagnostics assessments according to international standards and regulatory guidance.

Desirable:

• Working experience in different geographical regions, including resource-limited settings.
• Experience in development of target product profiles for diagnostic tests.
• Experience in implementation of diagnostic testing in resource-limited settings.
• Experience in assay development and/or evaluation.

Skills/Knowledge

• Knowledge of In Vitro Diagnostic manufacturing processes.
• Knowledge of WHO Technical specification guidance.

Languages required

Essential:

• Expert knowledge of English

Location

Off-site - Home based.

Travel

The consultant will be expected to travel.

Remuneration and budget (travel costs are excluded)

Remuneration

Band level C: USD 500 - 625 per day.

Living expenses (A living expense is payable to on-site consultants who are internationally recruited)

Not applicable.

Expected duration of contract

11 months part-time. Number of working days per month to be determined according to the needs of the programme.

Additional Information

• This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
• Only candidates under serious consideration will be contacted.
• A written test may be used as a form of screening.
• If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
• For information on WHO's operations please visit: http://www.who.int.
• WHO is committed to workforce diversity.
• WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
• Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
• WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter into practice.
• WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of final candidates.
• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between WHO and the Consultant.
• WHO shall have no responsibility whatsoever for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
• Consultants working in Switzerland must register with the applicable Swiss cantonal tax authorities and social security authorities, within the prescribed timeframes (Guidelines issued by the Swiss Mission are available at: https://www.eda.admin.ch/missions/mission-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html