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Technical support for VerifiNG self-benchmarking reports of Tunisian Pharmacy and Medicine Directorate (DPM)
The World Health Organization (WHO) plays a pivotal role in supporting countries in strengthening their regulatory systems and promoting equitable access to quality, safe, efficacious, and affordable medical products and health products. The WHO constitution affirms that the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being. Towards the achievement of such a noble objective, the WHO constitution states the functions of WHO, which include among others, assisting governments, upon request, in strengthening health services. Various World Health Assembly (WHA) resolutions encompass aspects of the need to promote the afore mentioned WHO role. It should be noted that regulators are an essential part of the health workforce and effective regulatory systems are an essential component of health systems and contribute to better public health outcomes. On the contrary, inefficient regulatory systems themselves can be a barrier to accessing safe, effective, and quality medical products.
WHO mandated by resolution WHA 67.20, supports countries to strengthen regulatory systems by:
• Building regulatory capacity in member states consistent with good regulatory practices, and
• Promoting regulatory cooperation, convergence, and transparency through networking, work-sharing, and reliance.
Benchmarking activities involve the evaluation of the medical products’ national regulatory system using the WHO Global Benchmarking Tool (GBT), generating and analyzing evidence of regulatory systems performance, and facilitating the formulation of Institutional Development Plans (IDPs) as a set of recommendations for the National Regulatory Authorities (NRAs) of member states. The consultant would assist in the verification of self-NRA benchmarking tool filled in by the different departments and institutions involved in the different regulatory functions in the WHO NRA GBT.
Output 1: Verification of the NRA inputs in the filled NRA global benchmarking tool related to the NRA self-evaluation
Deliverable 1.0: Review the NRA inputs for each sub-indicator and each indicator of each regulatory function in the self-NRA benchmarking tool that was filled out by the different departments in charge of the different regulatory functions of medicines and vaccines.
Output 2: Submit a verification report
Deliverable 2.0: Elaborate and submit a report that includes the comments on each NRA input in all sub-indicators/indicators of all regulatory functions and recommendations for improving the self-NRA benchmarking exercise.
Essential: University degree in pharmacy, medicine, pharmacology, chemistry, biochemistry, microbiology, or other health-related sciences.
Desirable: Postgraduate degree in pharmacy, medicine, public health, or any of the above sciences or management.
Essential: At least 5 years of national, regional, or international professional experience working in the area of regulation of medical products within the national or regional regulatory authority.
Good overall knowledge of regulatory systems strengthening and in-depth knowledge of the WHO global benchmarking tool, methodology of benchmarking and related WHO guidelines.
Experience as an assessor in participating in or conducting NRA benchmarking missions.
Experience working in collaboration with the World Health Organization is essential in order to understand WHO’s roles and core functions.
International experience is mandatory.
· Extensive knowledge of regulatory systems strengthening for medical products in the regulatory authority or related fields.
· Excellent ability to communicate and work in diverse cultural settings.
· Advanced computer literacy and knowledge of regulatory IT systems and databases.
· Good professional drafting and communication skills.
· Experience related to benchmarking of regulatory authorities in low- and middle-income countries (LMICs).
Essential: Expert knowledge of English and French language.
Remote assignment (Off-site: Home based)
Not required
· Remuneration: at Band level “B”
· Expected duration of the contract: 10 days – Start date: 11/09/2023
Enhanced WHO Global Competency Model: https://www.who.int/employment/WHO_competencies_EN.pdf?ua=
Interested candidates are strongly encouraged to apply online through Stellis. For assessment of your application, please ensure that:
a) Your profile on Stellis is properly completed and updated.
b) All required details regarding your qualifications, education, and training are provided.
c) Your experience records are entered with elaboration on tasks performed at the time.
Additional information