Consultancy on Country Regulatory Support, Manila

Organization: WHO

Country: Philippines

City: Manila

Office: WHO WPRO Manila

Closing date: Monday, 23 January 2023

WHO

Consultancy on Country Regulatory Support Individual consultant

Reference: WPRO/2023-01/DHS_EMT/189654

Beneficiary countries: Philippines

Published on: 09-Jan-2023

Deadline on: 23-Jan-2023 23:59 (GMT 8.00) Beijing, Perth, Singapore, Hong Kong

Description

BACKGROUND

Strengthening of the National Regulatory Authorities is one of the fundamental strategies for countries to advance Universal Health Coverage. Efficient regulatory systems will ensure that only medical products meeting appropriate standards of efficacy, safety and quality can enter the market.

WHO has been taking an active role in helping Member States to strengthen regulatory systems as part of the overall health systems strengthening, including facilitation of good decision-making processes, development of technical competency, harmonization and convergence of global norms and standards. Despite significant progress being made, many countries are still struggling to implement critical regulatory functions to the minimum level that is required by the World Health Assembly resolution WHA67.20 (2014). 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 introduction of a global benchmarking process to streamline strengthening activities.

The work of this consultancy contributes to country support on the overall implementation of the Western Pacific Regional Action Agenda on Regulatory Strengthening, Convergence and Cooperation for Medicines and the Health Workforce (RC68.R7, 2017).

PURPOSE/SPECIFIC OBJECTIVE OF THE ACTIVITY

The consultant will assist in the provision of country support aimed at strengthening regulatory systems for medical products in the Western Pacific Region and assist in the sustained regulatory management and response to public health emergencies of international concern.

METHODS TO CARRY OUT THE ACTIVITY

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: Output/s

Output 1: Strengthening capacity and capability of national regulatory authorities through benchmarking in the Western Pacific Region and technical support for the implementation of institutional development plans of the countries, including, but not limited to Cambodia, Lao PDR, Mongolia, Papua New Guinea, Philippines and Viet Nam and the Pacific Island countries.

Deliverable 1.1: Country specific benchmarking roadmap and its monitoring including pre-visit, self-benchmarking report, verification of the report, updated institutional development plan, terms of reference for benchmarking mission

Deliverable 1.2: Monitoring, technical support for and update of institutional development plans of the priority countries

Output 2: Cooperation and convergence activities by supporting the work of regulatory network initiatives in the Western Pacific Region through provision of technical assistance including organizing regional fora and meetings, drafting/reviewing technical specifications, standard operating procedures and guidance as requested by the countries.

Deliverable 2.1: 12th meeting of regional alliance operational guidance with program agenda, discussion papers, speaker nominations, and communications with speakers and participants

Deliverable 2.2: Presentations for technical agendas, draft summary (within 2 weeks from the meeting) and full (within 3 months from the meeting) meeting reports

Output 3: Sustained regulatory management and preparedness for the availability of medical countermeasures against public health emergencies of international concern

Deliverable 3.1: Regular update of clinical evidence and regulatory approvals of medical countermeasures against public health emergencies of international concern

Deliverable 3.2: Support and advice to countries on regulatory pathways and strategies for transitioning from emergency use authorisation to full product approval or other alternatives.

QUALIFICATIONS & EXPERIENCE

EDUCATION

University degree or higher in Medicine, Pharmacy, Chemistry or Biologicals or health-related sciences

Desirable: post-graduate (master’s level) degree in Public Health (or related field)

EXPERIENCE

Essential: three years or more of proven professional and working experience in clinical development or the regulation of medical products

Desirable: experience on benchmarking of national regulatory authorities in developing countries

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 on 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)

COMPETENCIES

Teamwork

Respecting and promoting differences

Communication

Knowing and managing yourself

Producing results

ADDITIONAL INFORMATION

Duration of contract

6 February 2023 - 29 December 2023

Place of assignment

The consultant will work off-site or on-site of the WHO WPRO based in Manila, Philippines. If needed, the consultant will be requested to travel based on discussion with supervisors.

Medical clearance

The selected Consultant will be expected to provide a medical certificate of fitness for work.

Travel

The Consultant is expected to travel on mission as needed.

All travel arrangements will be made by WHO - WHO will not be responsible for tickets purchased by the Consultant without the express, prior authorization of WHO. While on mission under the terms of this consultancy, the Consultant will receive subsistence allowance.

Visas requirements: it is the consultant’s responsibility to fulfil visa requirements and ask for visa support letter(s) if needed.

APPLICATIONS

Qualified and interested specialists should submit their CV and Expression of Interest {cover letter} to the Supply Officer through WP RO UNGM at wproungm@who.int > by 23 January 2023.

The cover letter should outline how their experience and qualifications make them a suitable candidate for this position and should include their proposed daily consultancy fee and availability.

Please use Tender Notice No. 189654 as subject to all submission. Only successful candidates will be contacted.

Thu Ha Le - wproungm@who.int

Email: wproungm@who.int

First name: Thu Ha

Surname: Le

UNSPSC

85000000 - Healthcare Services

85100000 - Comprehensive health services

85101700 - Health administration services

85101701 - Health policy

85101702 - Health legislation or regulations

85101703 - Health service planning

85101705 - Public health administration

85101707 - Health system evaluation services

Link to the organization’s job posting: https://unjobs.org/vacancies/1673293934865