BACKGROUND

Clinical trials are conducted as part of the medical products development before marketing authorization. Developers and manufacturers are extensively conducting clinical trials for medicines and vaccines in many countries. However, some countries with weak regulatory capacity face significant challenges in ensuring ethical and safe research, as they lack the needed infrastructure and skilled investigators.

WHO has been taking an active role in supporting Member States to ensure that well-conducted, blind randomized controlled trials (RCTs) are carried out and most importantly, to ensure that rights and well-being of human participants are protected. WHO provided support by facilitating good decision-making processes, technical competency development, establishing norms and standards. However, challenges are persistent because of various reasons including: changing regulatory landscape brought about by globalization, innovation and sophistication of health systems and the persistent lack of technical competence. These challenges have been aggravated by a pandemic situation, where the “standard” clinical trials design and execution are not applicable because the world is racing against time.

The consultant will support the work of WHO in strengthening clinical trial oversight in the region, especially for low- and middle-income countries and to ensure that the significant learnings from the current COVID-19 situation can be integrated with the Institutional Development Plans of the country in responding to future pandemic situation and health emergencies.

PURPOSE/SPECIFIC OBJECTIVE OF THE ACTIVITY

To support the regulatory systems strengthening programme within EMT team in the development and implementation of strategies and actions in strengthening Member States' clinical trial oversight with particular focus on COVID-19 vaccine introduction in the Western Pacific Region.

DESCRIPTION OF ACTIVITIES TO BE CARRIED OUT

The consultant will work with EMT mainly and closely coordinating with Vaccine-Preventable Diseases and Immunization team (on vaccine) to deliver the following:

Output/s

Output 1:  Monitor clinical trial developments of COVID-19 therapeutics and vaccines and present to NRAs and other partners.

• Deliverable 1.1: Monitoring sheet updated from time to time
• Deliverable 1.2: Presentation slides, briefing notes on research and development

Output 2:  Support WHO and countries in facilitating WHO solidarity trials on therapeutics and vaccines.

• Deliverable: 2.1 Briefing reports on solidarity trials including (number of countries participating, meeting reports)

Output 3: Support in implementing global benchmarking process and institutional development plans of the countries focusing on clinical trials oversight.

• Deliverable 3.1. Workplan for the implementation of priority countries Institutional Development Plan and meeting reports

Output 4: Assist in the review and development of country-specific guidelines for clinical trial oversights

• Deliverable 4.1: Review of guidelines of selected countries on clinical trial oversight

Output 5: Lead the capacity building activities for clinical trials (e.g. development of e-learning courses, facilitating trainings-regional or country support)

• Deliverable 5.1: Concept note of e-learning courses, planned training activities

Output 6: Assist in partnership and stakeholder coordination, participation to technical meetings with EMT, DVI and other relevant Offices in WHO and external partners

• Deliverable 6.1: Meeting reports

METHODS TO CARRY OUT THE ACTIVITY

The consultant will work with EMT mainly and closely coordinating with Vaccine-Preventable Diseases and Immunization team (on vaccine) to deliver the outputs.

QUALIFICATIONS & EXPERIENCE

EDUCATION

Essential: Advanced level university (Masters level of above) in pharmaceutical sciences public health or relevant health-related field.

Desired: Postgraduate degree in regulatory sciences.

EXPERIENCE

Essential: More than ten 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 clinical trials.

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 is for 6 months starting 15 June 2021

APPLICATIONS

Qualified and interested specialists should submit their CV to the Supply Officer through WP RO UNGM at < [email protected] > by 24 May 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. 128582 as subject to all submission. Only successful candidates will be contacted.