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Consultant Country Regulatory System Strengthening and Cooperation

World Health Organization

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Job Description

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Description

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The World Health Assembly (WHA) resolution number 67.20, 2014 emphasizes the role of World Health Organization (WHO) in strengthening regulatory systems for medical products from a public health perspective, and in supporting national regulatory authorities and relevant regional and international networks in this area.  Essential Medicines and Health Technologies Unit (EMT), Division of Health Systems and Services (DHS), Western Pacific Regional Office (WPRO), continues to support the strengthening of the regulatory systems in the Western Pacific Region (WPR). Despite significant progress, many countries are still struggling to implement critical regulatory functions to the minimum level required by the World Health Assembly resolution WHA67.20 (2014). Low- and middle-income countries (LMICs) in the region that rely largely on the importation of medicines and vaccines to meet growing public health demand are at greater risk for a lack of access to quality-assured medicines and health technologies.
Strengthening regulatory systems requires a wide range of knowledge and technical expertise in various regulatory functions. Most countries have limited resources to exert all regulatory functions, therefore strategies and approaches need to be resource-considerate and practical. Recent approaches include the promotion of regulatory cooperation, convergence, and harmonization to address regulatory capacity gaps between countries and the introduction of a global benchmarking process to streamline strengthening activities.
The work of this consultancy contributes to the evaluation of national regulatory systems, application of WHO evaluation tools, evidence generation and analysis of regulatory system performance, facilitating the formulation and implementation of institutional development plans and​ providing technical support to national regulatory authorities and governments.​
Planned timelines (subject to confirmation)
Under the supervision and guidance of the Medical Officer, RSS, EMT, DHS at the WHO Regional Office for the Western Pacific Region, the consultant will conduct desktop research, draft guidance documents and meeting reports, conduct in-country trainings and communicate with the national regulatory authorities (NRAs) and other stakeholders to deliver the following by the end of the contract period:
  • Supporting regional activities of regulatory cooperation and convergence through the work of regulatory network initiatives in the Region
  • Logistics and operations of the 13th Western Pacific Regional Alliance meeting of the national regulatory authorities with program agenda, discussion papers, speaker
  • nominations, and communications with speakers and participants
  • Presentations for technical agendas, draft summary (within 2 weeks from the meeting) and full (within 3 months from the meeting) meeting reports
  • Regulatory Systems Strengthening through building the capacity and capability of national regulatory authorities by using the WHO Global Benchmarking Tool (GBT) in the Western Pacific Region, generation of an institutional development plan, and providing technical support in its implementation. This support will be provided to countries including, but not limited to, Brunei Darussalam, Cambodia, Mongolia, Papua New Guinea, Viet Nam, and the Pacific Island countries.
  • Update of country-specific benchmarking roadmap and its progress including pre-visit, self-benchmarking report, verification of the report, updated institutional
  •  development plan, and terms of reference for the benchmarking mission.
  • Progress report of technical support for the implementation of the institutional development plans of the priority countries defined in Output 2
  • Sustained regulatory management and preparedness for the availability of medical countermeasures against disease outbreaks
  • Update of clinical research of medical countermeasures and new technologies against public health emergencies
  • Report of country progress in planning and implementation of medical countermeasures and new technologies for preparedness for future pandemics
Qualifications, experience, skills and knowledge, and languages:
Qualifications:
Essential:  
  • University degree in Medicine, Pharmacy, Chemistry or Biologicals or health-related sciences
Experience​​​​​​​:
Required:  
  • Minimum of five years of proven professional and working experience in clinical research or the regulation of medical products
Technical Skills & Knowledge:
  • Proven ability to plan and implement new strategies and activities to achieve a goal. Ability to function and communicate effectively. Broad knowledge of the regulation of medical products (e.g., review of product dossiers for quality, safety, and efficacy, pharmacovigilance, clinical trials, regulatory inspections, laboratory access and lot release, and market surveillance) is desirable.
  • Ability to work effectively with national regulatory authority experts and stakeholders.
Languages​​​​​​​:
Essential:
  • Fluent in English (writing, reading and speaking) 

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