B.Pharm
PharmD
MBA
Purpose of consultancy The consultant shall work in coordination with the Vaccines and Immunization Devices Assessment Prequalification Team (PQT) focal points: To review the safety and efficacy of specific vaccines to ensure that they fulfil the requirements as indicated in the relevant WHO and other international standards. To raise queries in case of incomplete data and assess the adequacy of the manufacturers’ responses. To make a recommendation based on the adequacy of the vaccine as per the acceptability of the WHO vaccine prequalification dossier (VPQD) in principle for purchase by UN agencies. In order to fulfill the purpose
the consultant should: Assess what published guidelines
requirements/recommendations
and international guidance documents are available from WHO and other regulatory agencies that are relevant for the evaluation of a vaccine. Conduct a search for relevant publications with evidence of scientific consensus with regards to safety
immunogenicity
or clinical efficacy of a vaccine. All recommendations by the consultant are advisory to WHO
who retains full control over any subsequent decisions and actions
including whether to publish the findings and recommendations to accept the vaccine for acceptability in principle for purchase by UN agencies. Background The World Health Organization (WHO)
through its Regulation and Prequalification Department provides advice to the United Nations Children’s Fund (UNICEF) and other United Nations agencies on the acceptability
in principle
of vaccines considered for purchase by such agencies. This service is called prequalification. The purpose of the WHO prequalification assessment is to provide assurance that candidate vaccines: (a) meet WHO recommendations on quality
safety and efficacy
including compliance with WHO’s recommended standards for good manufacturing practices (GMP) and good clinical practice (GCP); and (b) meet the operational packaging and presentation specifications of the relevant United Nations agency. Prequalification also supports the specific needs of national immunization programmes with regards to vaccine characteristic such as potency
thermostability
presentation
labelling and shipping conditions. The aim is to ensure that vaccines provided through the United Nations for use in national immunization services in different countries are safe
effective and suitable for the target populations at the recommended immunization schedules and with appropriate concomitant products. This important work is carried out with the support of international experts in Non-Clinical
Clinical and Chemistry
Manufacturing and Controls (CMC) evaluation of biological medicinal products
specifically vaccines. WHO is making a call to increase the number of consultants/experts available to support this very important public health responsibility. Deliverables Produce timely assessment reports (AR) of the reviewed information. Report on critical
major
and other deficiencies detected during the review of the documentation/data (assigned to the consultant). Assess the applicant's responses to queries raised in the AR and decide on the adequacy of each response. Several sets of queries may be necessary. Provide WHO with a recommendation and final remarks on the evaluation based on the documentation assigned for review to the consultant. This should be based on the most updated scientific and regulatory grounds. Qualifications
experience
skills and languages Educational Qualifications: Essential: Advanced university degree in medicine
biology
or pharmacy. Desirable: A postgraduate degree in biostatistics or in epidemiology with focus on infectious diseases or related science. Experience Essential: Over ten years’ experience in the field of infectious diseases
immunization and regulation of biological products including vaccines acquired by working in the field of immunization or community and preventive medicine at country or international level and/or with a National Regulatory Authority (NRAs)
with at least 5 years respective experience at the national level. Extensive experience in the evaluation of clinical trials for vaccines. Desirable: Experience at international level. Work experience in developing countries. Skills: Essential: Solid clinical scientific background
particularly in the area of infectious diseases and vaccines Expert must have technical skills and knowledge on the development
strengthening and monitoring of regulatory systems for vaccines
drugs
biologicals
and medical devices. Desirable: Familiarity with WHO prequalification procedure
with WHO activities in strengthening the capacity to regulate clinical trials
vaccines as a biological medical product and /or with the NRA assessment procedure. Languages required: Essential: Expert knowledge of English. Location Off site: Home-based. Travel The consultant is not expected to travel.