E-DRUG: STC for strengthening systems of medicines regulation & supply Cambodia
------------------------------------------------------------------------------------------------
Short Term Consultant (STC) for Essential Medicines and Pharmaceutical Policy for strengthening systems of the medicines regulation and supply management Phnom Penh, Cambodia
Qualified and interested specialists should submit their CV and Expression of Interest to:
The Supply Officer through WP RO UNGM at
wproungm@who.int
by April 25
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.
TITLE: SHORT TERM CONSULTANT (STC) for strengthening systems of medicines regulation and supply management
20 May -20 December 2019 (exclusive of travel)
Application Deadline: 25 April 2019
You can follow the procedure and find the full TORs to find more information in the following link:
https://www.ungm.org/Public/Notice/88841
1. BACKGROUND
The Department of Drugs and Food is the regulatory authority under the Directorate General for Health, Ministry of Health Cambodia hat is authorized to ensure the safety and quality of drugs, medical devices, general medical items, cosmetics and food in the country. In addition to DDF, the following regulatory and supply agencies are responsible for ensuring the availability and accessibility of medicines and health products throughout the country. The National Health Products Quality Control Centre (NHQC) is responsible for medicines and health products quality analysis and it has a vision to gain reputation as an internationally respected centre of excellence by implementing international standards. The Central Medical Store (CMS) receives, stores and distributes pharmaceutical products to the public sector. Some priority activities of DDF and NHQC in 2019 are listed below:
- Introduction of the quality management system
- Development of a new pharmaceutical strategic plan
- Revision of the law and regulations on pharmaceuticals
- Launching and implementation of the online registration system of pharmaceutical products
- Introduction and implementation of the risk-based post-marketing surveillance and strengthening pharmacovigilance
- Finalization of the national medicines formulary
- Regulation of the use of antimicrobials, etc
2. PURPOSE/SPECIFIC OBJECTIVE OF THE ACTIVITY
Under the direction of the WHO Country Office in Cambodia and in close collaboration with Ministry of Health, the consultant will:
1. provide the necessary expertise and leadership in the review of the Pharmaceutical Sector Strategic Plan, 2013-2018 and the Pharmaceutical Management Law, which are subject to be revised and updated, to ensure that effective plans and legislative framework are in place. These include a completion of the mapping and drafting of pharmaceutical legislation and relevant laws and regulations as well as drafting a next pharmaceutical sector plan in close collaboration with national counterparts and legal expert.
2. Provide overall management, coordination, implementation, monitoring of work plans of the DDF and donor funded work plans, aimed at strengthening the health system in Cambodia and in particular Global Fund Resilient Sustainable Systems for Health (RSSH) -Procurement and Supply Chain Management (PSCM) workplan;
3. provide technical support to national counterparts to build their capacities for implementing the logistics management information system (LMIS) focusing on the effective medicines supply chain management and developing and reviewing relevant guidelines, tools and training materials;
4. provide technical support to strengthening regulatory systems of Department of Drugs and Food and the capacity of National Health Product Quality Control Centre for analytical testing;
5. contribute to improve coverage and quality of service delivery by promoting safe and rational use of medicines including antimicrobials. This includes not limited to finalization of the national medicines formulary, development of essential lists of medical devices, in-vitro diagnostics, antibiotic stewardship guidelines, clinical practice/standard treatment guidelines etc;
6. collaborate with other government and international agencies to implement the multi-sectoral action plan on antimicrobial resistance taking into account the 'one health approach';
7. develop standards, norms and guidelines on regulatory system strengthening by adapting international and regional guidelines as required;
8. support the WHO Health Systems Development team in providing other technical assistance as needed; and
9. submit a report at the end of the consultancy.
3. DESCRIPTION OF ACTIVITIES TO BE CARRIED OUT
In close coordination with Department of Drugs and Food, Ministry of Health and WHO:
1. Review of key documents: polices, plans, strategies, laws and regulations, guidelines, standards and tools, training materials
2. Development and finalization of guideline for medicines regulation: marketing authorization guidelines and post-marketing surveillance
3. Development of standard operating procedures (SOPs) to support the implementation of guidelines
4. Training of regulators on relevant topics such as scheduling of medicines, pharmacovigilance
5. Devise training agenda on areas of pharmaceutical policies
6. Facilitation of stakeholder consultations on medicines areas and interview and consultations with staff and responsible persons from Ministry of Health
7. Presentation of best practices and experiences on ensuring access to good quality medicines and health products
8. Develop a final report including next steps and recommendations for implementation
4. METHODS TO CARRY OUT THE ACTIVITY
The following deliverables of the assignment have been identified and will be tied to the release of funds.
Output 1: The Consultant is expected to develop guidelines, tools and standard operating procedures to effective regulation of medicines and health products in Cambodia.
Deliverable 1.1: evaluation report of the pharmaceutical sector strategic plan (to be initiated)
Deliverable 1.2: draft pharmaceutical sector strategic plan for next five or ten years (to initiate)
Deliverable 1.3: gap analysis of pharmaceutical and related laws and regulation (in progress)
Deliverable 1.4: draft legal framework of pharmaceutical legislation (in collaboration with a legal consultant)
Deliverable 1.5: meeting report on the launch of the multisectoral action plan antimicrobial resistance (draft document is already finalized for endorsement)
Output 2: strengthening medicines supply chain management
Deliverable 2.1: revised tools and guidelines on supply chain management including e-LMIS
Deliverable 2.2: evaluation report of the e-LMIS in collaboration with other partners as required when needed
Output 3: training and coaching of regulatory staff on effective medicines regulation and development of tools and guidelines
Deliverable 3.1: launching report of the online registration system of pharmaceutical products (the system is currently being developed and will be beta tested by May 2019)
Deliverable 3.2: final guidelines and tools for medicines registration/marketing authorization and training reports of staff on these tools (in draft)
Deliverable 3.3: finalized guidelines on risk-based post-marketing surveillance and regulatory inspections (draft guidelines are in place) and training reports of inspectors
Deliverable 3.4: power point presentations on best practices and experiences on ensuring access to good quality medicines and health products delivered to regulatory staff
Output 4: guidelines and tools for rational use of medicines including antimicrobials
Deliverable 4.1: guidelines for implementation of antimicrobial stewardship (in process)
Deliverable 4.2: training materials on rational use of medicines and antimicrobial stewardship
Deliverable 4.3: developed lists of medical devices, in-vitro diagnostics, priority list of assistive products based on the WHO model lists
Deliverable 4.4: dissemination report of the national medicines formulary (the formulary is already edited)
Output 5: submission of a technical report at the end of the consultancy including all deliverables described in output 1-4
Deliverable 5.1 technical report with all the deliverables
5. QUALIFICATIONS & EXPERIENCE
EDUCATION
Essential: Post-graduate degree in Pharmacy or related field from a recognized university
Desirable: Proficiency with evaluation process an methodologies, including training in regulatory system strengthening, procurement supply management, evidence- based medicine
EXPERIENCE
Essential: At least 7 years of proven professional and working experience in the areas of medicines regulation systems and procurement and supply management
Desirable:
experience in developing national medicines policies, pharmaceutical law and regulations, medicines quality control and assurance in resource-limited settings.
TECHNICAL SKILLS & KNOWLEDGE
- Knowledge of the specific or technical area of public health
- Ability to contribute to the development of regulatory norms and standards, as well as training materials
- Capacity to plan and conduct operational activities with political and technical elements
- Ability to establish harmonious working relationships as part of a team, adapt to diverse educational and cultural backgrounds, and main a high standard of personal conduct
- Excellent communication and presentational skills
- Ability to work effectively with national regulatory authority experts and stakeholders
LANGUAGES
Essential: Fluent in English (writing, reading and speaking)
COMPETENCIES
- Communicating in a credible and effective way
- Producing results
- Moving forward in a changing environment
- Fostering integration and teamwork
- Building and promoting partnerships across the organization and beyond
ADDITIONAL INFORMATION:
APPLICATIONS
Qualified and interested specialists should submit their CV and Expression of Interest to
the Supply Officer through WP RO UNGM at wproungm@who.int
by April 25
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.
Supply Officer through WP RO UNGM at wproungm@who.int