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 supports, 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 the provision of country support aimed at strengthening regulatory systems for medical products in the Western Pacific Region.

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:  To assist in promoting 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, and operationalize actions points as agreed by the Member States (e.g. setting up website, establishing establishment of focal points networks, updating of country profiles and publications as agreed by the Member States)

Deliverable: 1.1 draft planning document, draft meeting agenda, draft profiles and publications, draft meeting reports.

Output 2: To assist in the WHO COVID-19 response in the area of vaccination in the area of research and development by monitor clinical trials and registration of innovative products against novel coronavirus disease (Covid-19). The consultant will provide country support by ensuring regulatory requirements are compiled for vaccine access through COVAX.

Deliverable 2.1. draft briefing notes, draft presentations and draft reports

Output 3: To assist in the data collection to be used for monitoring of access and availability of COVID-19 vaccines in the region.

Deliverables 3.1:  draft briefing notes, draft presentations and draft reports

Output 4: To assist and participate in the global benchmarking process of NRAs in WPR countries and in the implementation institutional development plans of the countries focusing on marketing authorization and registration of medical products and post market surveillance. The consultant will support provision of training, drafting regulations, drafting standard operating procedures and drafting briefing notes as requested by the countries.

Deliverable 4.1: Draft report on the progress of global benchmarking in WPR countries.

To work with the EMT team on other relevant activities such as strengthening procurement systems in the WPR.

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:

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
• • Good understanding of the overall regulatory systems of medical products

LANGUAGES

Fluent in 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 is from 3 January 2022 until 15 June 2022

APPLICATIONS

Qualified and interested specialists should submit their CV to the Supply Officer through WP RO UNGM at < wproungm@who.int > by 8 December 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. 156839 as subject to all submission. Only successful candidates will be contacted.