Consultancy - Support Regulatory Systems Strengthening program in the Pacific Islands Countries (PICs)
Support Regulatory Systems Strengthening program in its activities related to medical product registration and marketing authorization in the context of the initial phases of operationalization of the sub-regional regulatory platform for medical products in the Pacific Islands Countries (PICs)
BACKGROUND
Access to safe, effective, quality and affordable essential medicines is important in achieving universal health coverage (UHC) and the Sustainable Development Goals. In the Pacific island countries (PICs) there are many challenges on access to essential medicines, including, availability, affordability, and quality and safety due in part to geographical challenges and weak pharmaceutical systems. Most countries do not have fully functional regulatory systems in place and weak procurement and supply chain management often lead to low availability and wastage of essential medicines.
The Action Agenda on Regulatory Strengthening, Convergence and Cooperation for Medicines and the Health Workforce endorsed by the Member States at the 68th Regional Committee Meeting supports regulatory strengthening, convergence and cooperation in countries. The PICs can benefit from sub-regional regulatory cooperation as most are unable to build and sustain fully functional regulatory authorities due to constraints in human and financial resources.
The establishment of a subregional regulatory platform to strengthen and perform regulations of medicines, vaccines and other pharmaceuticals in the PICs was endorsed by health leaders from across the Pacific at the 13th Pacific Health Ministers Meeting (PHMM) in French Polynesia. Some of the priority regulatory functions that the platform will support are the strengthening of PICs’ mechanisms for registration and marketing authorization of medical products as well as the establishments of national pharmacovigilance systems.
The work of the consultant will be to support Member States in the Pacific and coordinate and collaborate with National Regulatory Authorities to implement country and subregional activities that can strengthen pharmaceutical system in the Pacific, with a focus on product registration and accessibility.
PURPOSE/SPECIFIC OBJECTIVE OF THE ACTIVITY
Support Regulatory Systems Strengthening program in its activities related to medical product registration and marketing authorization in the context of the initial phases of operationalization of the sub-regional regulatory platform for medical products in the Pacific Islands Countries (PICs)
DESCRIPTION OF ACTIVITIES TO BE CARRIED OUT
Output/s
Output 1: Assessment on the status of product registration systems in each of the Pacific Islands Countries
Deliverable 1.1: Assessment report detailing the current status and situational analysis of medical products registration systems and tools in the PICs;
Deliverable 1.2: Listing of products currently marketed and/or registered in PICs, including information about manufacturers and suppliers.
Output 2: Proposal for product registration support through the sub-regional platform for PICs
Deliverable 2.1: Report describing strategies to strengthen product registration systems in the PICs and proposal for technical support through the subregional platform, including detailed processes and requirements to be followed and resources needed.
And provide other necessary supports as requested by the supervisor.
METHODS TO CARRY OUT THE ACTIVITY
The consultant will support different activities in the field of product registration/marketing authorization at:
Country Level:
- • Support the revision of existing legislative frameworks for medical product registration in the PICs;
- • Interview key stakeholders (Chief pharmacists, procurement managers, etc.) in each selected country; collect relevant information and data from selected countries and develop a database of medical products, suppliers and manufacturers present in the PICs;
- • Support the implementation of country workplans in the area of product registration of medical products;
Subregional level:
- • Carry out research on options to support product registration through the subregional platform;
- • Support information sharing among PICs and facilitate consultations with Member States on Medical Product regulation across the Pacific countries;
- • Support Product Verification Process-related activities: drafting SOPs and guidelines, support revision of technical documents for selected medical products
- • Any other activities as needed in discussion with supervisor
ACTIVITY COORDINATION & REPORTING
The selected Consultant will work under the supervision of:
Responsible Officer: Ms Eva Mata, Technical Officer, WHO DPS Office
Manager: Dr Akeem Ali, Team Leader, PHS, DPS Office
QUALIFICATIONS & EXPERIENCE
Education
Essential: University degree in pharmaceutical sciences, medicine, or relevant health discipline with postgraduate degree in a relevant field from a recognized university.
Desirable: Postgraduate qualification (MsC or PhD) in Pharmaceutical regulatory affairs; Regulatory Affairs Professional Society Certification (RAC)
Experience
Essential:
Minimum of seven years of experience in pharmaceutical and medical products regulation, including product registration and dossier assessment, at international level.
Desirable:
Experience in providing technical assistance to National Regulatory Authorities in developing countries and Small Island Developing States (SIDS). Experience in revising/updating medical product registration processes, including the development and implementation of electronic registration systems. Experience in regulatory convergence and cooperation initiatives.
Technical Skills & Knowledge
- • Experience conducting multi-country studies in low- and middle-income countries
- • Good interpersonal skills and capable of facilitating discussion and teamwork
- • Good analytical thinking and writing skills
Languages
High level of written and spoken English
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
Duration of Contract: 18 April - 31 December 2022
Place of assignment: Suva, Fiji and remote work
Travel: The consultant might need to travel to selected countries in the Pacific.
Payment terms
Payment will be made in the following instalments:
- • 10% - Submission of an initial workplan
- • 25% - submission of a first interim report: Assessment report detailing the status and situational analysis of medical products registration systems and tools in the PICs (deliverable 1.1)
- • 25% - Submission of a second interim report: Listing of products currently marketed and/or registered in PICs, including information about manufacturers and suppliers (Deliverable 1.2)
- • 40% - Submission of final technical report describing strategies to strengthen product registration systems in the PICs and proposal for technical support through the subregional platform (deliverable 2.1)
APPLICATIONS
Qualified and interested specialists should submit their CV {for individual contractors} and Expression of Interest {cover letter} to the Supply Officer through WP RO UNGM at < wproungm@who.int > by 7 April 2022.
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. 171032 as subject to all submission. Only successful candidates will be contacted.
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