Consultancy to strengthen national regulatory systems for all medical products, with particular focus on vaccines and medicines

Item Description:

The World Health Organization (WHO) was established in 1948 as a specialized agency of the United Nations. The objective of WHO (www.who.int) is the attainment by all peoples of the highest possible level of health. “Health”, as defined in the WHO Constitution, is a state of complete physical, mental and social well being and not merely the absence of disease or infirmity. WHO’s main function is to act as the directing and coordinating authority on international health work.

The Western Pacific Regional Office (WPRO) is one of the six regions of the World Health Organization. Headquartered in Manila, Philippines, we work with health authorities and other partners in 37 countries and areas with more than one quarter of the world’s population.

BACKGROUND

The National Regulatory Authority (NRA) has the duty to ensure that all available medical products, whether imported or manufactured locally, are of assured quality, safe and effective. The NRA ensures that the manufacturers adhere to approved standards of good manufacturing practices and product quality specifications. The effectiveness of procedures through which the NRA confirms the assurance of quality provided by the manufacturer will depend on sufficient number qualified regulatory workforce and sustainable finance to hire staffs and carry out activities. Poor or inadequate regulation may lead to the prevalence of substandard and falsified medicines and vaccines on national markets. This may result in serious harm to the health of individual consumers and to the health of the public. Furthermore, it may affect public confidence in medical products and the regulatory system.

World Health Organization (WHO) has been mandated to assist the Member States on regulatory issues such as assessment of regulatory capacities and building skills of government employees. But the greater focus is being given to stimulate the commitment of Member States to effective regulation and continual improvement.

WHO periodically conducts the National Regulatory Authority (NRA) assessments for vaccines and medicines in countries, where the maturity level of the regulatory system is evaluated; areas for improvement, as well as reasons for gaps, are identified. Based on these findings, assessors provide recommendations that help formulate the institutional development plan (IDP). Upon request from the Member States, WHO provides technical assistance through coordination with partner organizations and institutions.

PURPOSE/SPECIFIC OBJECTIVE OF THE ACTIVITY

The overall purpose of the Consultancy is to strengthen national regulatory systems for all medical products, with particular focus on vaccines and medicines, in Mongolia. The scope of the Consultancy will cover all areas of critical regulatory functions that focus life cycle management of medical products from market entry to exit.

This proposal invites a specialist level consultant, who has more than 6 years of experience in areas of vaccine or medicine research and development or national regulatory authority, being capable of providing advice to the national authority of Mongolia on implementing national medicine policy, pharmaceutical sector strategic plan, and assistance on self-benchmarking and establishment and facilitation of implementation of an institutional development plan in close coordination with WHO.

DESCRIPTION OF ACTIVITIES TO BE CARRIED OUT

Under the supervision and guidance of the Health Systems Team Coordinator of WHO Country Office Mongolia and the Medical Officer for Regulatory Systems Strengthening of WHO Western Pacific Regional Office, the consultant will work together with counterparts and development partners to perform the following activities:

1. Review the IDP of the NRA of Mongolia and plan for priority actions to be implemented within the contract period;
2. Coordinate, communicate and consult with Major Offices of WHO at three levels and Ministry of Health in planning, implementing, monitoring and reporting IDP activities;
3. Assist in preparation of MOH’s self-benchmarking and WHO’s international assessment and
4. Organize collaborative NRA-strengthening activities with MOH together with WHO partners;
5. Assist in facilitating, monitoring and evaluating in-country training, implementation workshops, and global learning opportunities for vaccine and medicine quality training.

METHODS TO CARRY OUT THE ACTIVITY

Output 1: Develop a work plan on the implementation of activities for Regulatory Systems Strengthening and final consolidated report with self-assessment of consultant performance evaluation

• Deliverable 1.1: draft work plan inclusive of introduction and background, objectives and methodology to carry out the mission, and list of activities with a proposed target timeline
• Deliverable 1.2: final consolidated consultancy report with high-level recommendations
• Deliverable 1.3: self-assessment of consultant performance evaluation

Output 2: Provide technical assistance in planning, monitoring and review of the Institutional Development Plan of MOH

• Deliverable 2.1: A working table of bi-monthly monitoring and review of the IDP
• Deliverable 2.2: List of priority activities planned or conducted which includes supporting documents (e.g. meeting minutes, note for the record, mission report, attendance sheets, terms of references, and other documents)

Output 3: Facilitate preparation of self-benchmarking, in-country capacity building activities and support the NRA to be part of international meetings, training and conference to strengthen relevant NRA functions.

• Deliverable 3.1: Consolidated self-benchmarking report
• Deliverable 3.2: List of areas for improvement and recommendations that can be transformed into IDPs
• Deliverable 3.3: Reports of in-country workshops and meetings.

QUALIFICATIONS & EXPERIENCE

EDUCATION

Essential:  University degree or higher in Medicine, Public Health, Pharmacology, Biology, Microbiology, Immunology or other health-related sciences

Desirable: Certificate of QMS training; GMP training

EXPERIENCE

Essential: more than six years of proven professional and working experience in research or regulation of medical products

Desirable: Experience in designing, implementing and evaluating programs and projects

TECHNICAL SKILLS & KNOWLEDGE

• Effective communication skills
• Advanced knowledge on institutional administration, medicines or vaccines regulatory system and pharmaceutical supply chain management
• Ability to work effectively and generate outputs in a timely manner

LANGUAGES

• Written and spoken fluency in English is essential.

COMPETENCIES

• Technical Expertise
• Overall Attitude at Work
• Teamwork
• Respecting and Promoting Individual and Cultural Differences
• Communication
• Producing Result

ADDITIONAL INFORMATION:

APPLICATIONS

Qualified and interested specialists should submit their CV {for individual contractors} or Company Profile {for institutional applications} and Expression of Interest {cover letter} to the Supply Officer through WP RO UNGM at < wproungm@who.int > by 26 September 2019.

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. WPRO/2019-09/EMT_DHS/TN96632/bab as subject to all submission.  Only successful candidates will be contacted.

Peter Ellison – wproungm@who.int, Tel: +63 5289655, Fax: +63 5252512
Email: wproungm@who.int
First name: Peter
Surname: Ellison
Telephone country code: Philippines (+63)
Telephone number: 5289655
Telephone extension: 89655
Fax country code: Philippines (+63)
Fax number: 5252512