Regulatory System Strengthening – Country Support

BACKGROUND

Strengthening of the National Regulatory Authorities (NRAs) is one of the fundamental strategies for countries to advance Universal Health Coverage. Efficient regulatory systems will ensure that only products meeting appropriate standards of efficacy, safety and quality can enter the market especially in the context of Covid-19 pandemic.

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, technical competency development, establishing norms and standards. However, despite all these support, many countries are still struggling to implement all regulatory functions due to various reasons including: changing regulatory landscape brought about by globalization, innovation and sophistication of health systems and the persistent lack of technical competence.

Strengthening of regulatory systems is very complex and it requires wide range of knowledge and technical expertise. In reality countries cannot perform all regulatory functions hence strategies and approaches needs 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 global benchmarking process to streamline strengthening activities.

The work contributes to country support on Covid-19 regulatory response and in the overall implementation of the Western Pacific Regional Action Agenda on Regulatory Strengthening, Convergence and Cooperation for Medicines and the Health Workforce.

PURPOSE/SPECIFIC OBJECTIVE OF THE ACTIVITY

The consultant will assist in strengthening regulatory systems for medicines and vaccines on the assurance of the quality, safety and efficacy/effectiveness in the Western Pacific. Specifically, the consultant will be involved in country support plan on registration of innovative products against novel coronavirus disease (COVID-19), benchmarking, conducting country capacity building and promotion of cooperation and convergence within regional alliance of national regulatory authorities. 

DESCRIPTION OF ACTIVITIES TO BE CARRIED OUT

Under the supervision of Medical Officer, Essential Medicines and Health Technologies the contractual partner will deliver the following outputs:

Output/s

Output 1:  Research and literature review of therapeutics and vaccines in the pipeline against Covid-19.

Deliverable 1.1: Briefing report on the therapeutic and vaccines against Covid-19, updated from time to time.

Output 2:  Support on access to medicines and vaccines against Covid-19.

Deliverable 2.1: Draft report on regulatory preparedness including country's participation to WHO emergency use listing, donations and laboratory testing.

Deliverable 2.2: Draft report on mapping of country's pharmacovigilance capacity and preparedness.

Output 3: Country support on strengthening regulatory systems.

Deliverable 3.1: Workplan for the implementation of priority countries Institutional Development Plan. 

Output 4: Technical support for the Regional Forum, Meeting, Workshop and the development of communication platform for NRAs in the Western Pacific Region

Deliverable 4.1: Agenda items for the regional forum, meeting, workshop, meeting reports and development of communication platform (website) for NRAs in the western pacific region.

METHODS TO CARRY OUT THE ACTIVITY

Desktop research, draft guidance documents and meeting reports, conduct in-country trainings and communicate with the NRAs and other stakeholders.

QUALIFICATIONS & EXPERIENCE

EDUCATION

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

Desirable: post-graduate degree

EXPERIENCE

Essential: More than five years of proven professional and working experience in regulation of medical products and developing and managing systems within a medicine regulatory authority in developing countries and/or ASEAN countries is highly desirable.

Experience on benchmarking of National Regulatory Authorities and provision of trainings on marketing authorization and registration of medical products.

TECHNICAL SKILLS & KNOWLEDGE

• • Proven ability to plan and implement new strategies and activities to achieve a goal. Ability to function effectively and effective communication skills. Sufficient 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

Fully fluent written and spoken English is essential.

COMPETENCIES

• • Communicating in a credible and effective way
• • Producing results
• • Moving forward in a changing environment
• • Fostering integration and teamwork
• • Knowing and managing yourself

ADDITIONAL INFORMATION:

• • The contractor will work in close collaboration with DHS/EMT
• • Duration of contract: 26 March 2021 - 31 December 2021

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 18 March 2021.

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. 123325 as subject to all submission. Only successful candidates will be contacted.