The department of Essential Medicines and Health Products (EMP) works with Member States and partners to improve the access to essential medicines and other health technologies of assured quality for patients, and to promote that these are used rationally.
EMP works with the Health Systems and Innovation (HIS) cluster departments in the wider framework of Universal Health Coverage and category 4 of the Global Programme of Work, and cooperates with disease-oriented programmes (among others influenza, HIV/AIDS, TB, malaria, reproductive health, maternal and child health, immunization, NCDs and mental health) towards the Millennium Development Goals.
The Department works with a wide range of UN organizations, international partners, expert networks, and WHO Collaborating Centers. The objective of the Regulatory Systems Strengthening Team (RSS) within the Regulation of Medicines and other Health Technologies Unit (RHT) is to support all member states to strengthen their capacity so that they will have regulatory systems to ensure that all medical products and other health technologies meet internationally recognized standards of quality, safety and efficacy. From this perspective, RSS contributes to facilitate access to medical products of assured quality and to strengthen health systems in member states. The Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to vaccines and other benefits (the PIP Framework) is a 2011 World Health Assembly (WHA) resolution on improving pandemic preparedness and response globally. The Framework establishes a PIP Benefit Sharing System that includes annual partnership contributions (PC) to WHO from pharmaceutical manufacturers, some of them using the WHO Global Influenza Surveillance and Response System (GISRS). Robust regulatory systems are unquestionably crucial to achieve universal access to essential medicines and health products with several WHA resolutions backing up the mandate to strengthen them. In 2012, the PIP Advisory Group (AG) recommended the investment of PIP PC on regulatory capacity building in priority countries. In 2013, the WHO Director-General endorsed the AG recommendations and approved the implementation plan of the 2013-2016 PIP Framework-Partnership Contributions. The Technical Officer in RSS would assist in the implementation the PIP Framework and the use of PC on regulatory capacity building for health products (vaccines, antivirals and diagnostics) as part of national pandemic influenza preparedness in priority countries.
Description of duties:
Under the guidance of a Scientist in the Capacity Building and Harmonization Support group of the RSS team, the incumbent:
– provides input on the development of WHO guidelines on regulatory preparedness for non-vaccine producing countries that enables them to expedite approval of influenza vaccines used in national immunization programmes and/or deployed by United Nations agencies in response to a pandemic emergency;- contributes to building and strengthening National Regulatory Authority (NRA) capacity to regulate health products and technologies via NRA assessments, Institutional Development Plan (IDP) elaboration and implementation to address regulatory gaps, and the use of WHO tools for planning, monitoring, evaluating and reporting;
– consolidates the implementation of NRA IDPs in Pandemic Influenza Preparedness (PIP) priority countries, develops terms of reference, estimates activity costing, organizes and carries out priority activities in coordination with WHO regional and country offices as needed, identifies experts for country missions, identifies NRA/ Expanded Programme on Immunization (EPI) representatives to attend trainings /workshops/meetings, and, organizes and conducts country visits as needed;
– assists priority countries to adopt a common regulatory approach for expedited approval of either WHO prequalified influenza products (vaccines, antivirals and diagnostics) or products required to address disease outbreaks and/or public health emergencies i.e. pandemic influenza;
– maps countries that have licensed seasonal and pandemic influenza vaccines in all regions and those that accept the WHO expedited review/collaborative procedure in all regions;
– produces quality written reports with recommendations, documents work in the NRA activity planning and monitoring system (APMS), and reports back to and plans activities with the RSS PIP responsible officer;
– performs all other related duties as assigned.
Duty Station: Geneva, Switzerland
Application deadline: 2 September 2015
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