Consultant on Development of the Verification System in Ukraine
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International non-profit organization Management Sciences for Health (MSH) implementing in Ukraine the USAID funded Safe, Affordable and Efficient Medicines (SAFEMed) project is looking for a Consultant on development of the Verification System in Ukraine.
Duration of duties:
The consultancy is effective from on/about February 1 until September 31, 2019.
Currently, developed countries across the world are actively involved in establishing technologies and systems to track individual packs of medicines from manufacturer to consumer. This technology is improving identification of counterfeit and sub-standard medicines and instances of substitution of authentic product with product that is not the same. Countries around Ukraine are adopting such systems to increase supply chain transparency, reduce the risk of counterfeit medicines, and increase quality assurance capability. Ukraine risks being left behind and becoming a destination of choice for non-compliant medicines unless the country adopts similar technologies. In line with the MOH strategy, SAFEMed is providing technical assistance to the MOH to:
- Understand the environment and technologies around verification (or serialization, as it is also known) and
- Develop a national strategy and an implementation plan for adopting such technology in Ukraine moving forward.
The purpose of this consultancy is to build better understanding of the current environment for adapting national medicines verification strategy through a detailed landscape analysis, interviews with key stakeholders and thought leaders, and jointly with SAFEMed staff provide a set of evidence-based recommendations to the MOH and USAID on the development of the national medicines verification strategy and an implementation plan.
- Conduct literary review on the subject verification in Ukraine and appropriate countries.
- Conduct set of initial meetings with MOH leadership for finalize the scope of work and the timeline for this consultancy, to determine roles and responsibilities within the Ukrainian government.
- Cooperate with the MOH teams impacted by medicines validations
- Cooperate with the owner of the MOH business process re-engineering to identify scope and point of contact within the MOH and state authorities.
- Cooperate with all MOH representatives from different impacted functions to determine impact and limitations.
- Cooperate with SEC and SDS Information Technology to discuss technical options in order to:
- Determine the high-level architecture and design, including limitation regarding the use of third-party applications and development resources outside of Ukraine.
- Identify any regulations needed to be changed or new standards (i.e. GS1) that need to be implemented.
- Identify API standards
- Identify security requirements.
- Meet with at least five international (EBA/ACC) and five Ukraine-only pharmaceutical manufacturers to review the MOH medicine verification strategy as well as to determine cost, timelines and limitation for manufacture implementation of medicines verification.
- Meet with customs and law enforcement representatives to review the MOH strategy for medicines verification and to determine specific requirements for integration with customs and law enforcement processes.
- Meet with 2-3 pharmaceutical most influential distributors to review the MOH strategy for medicines verification and to determine specific requirements for integration with pharmaceutical distributor.
- Review the existing RFI results and the European Medicine Verification Organization (EMVO) Model.
- Work with the SAFEMed staff to document assumptions and recommended approaches for medicines verification in Ukraine.
- Develop a series of questions for the stakeholder community.
- Meet with the representatives of 2-3 hospitals and 5-6 pharmacies networks to review the MOH strategy for medicines verification and to determine specific requirements for integration with hospitals and pharmacies.
- Meet with external stakeholders – information technology providers and third-party solutions
- Contact local information technology development companies who have worked with the MOH to understand the size and cost of developing the software locally.
- Identity any regulatory and standard changes necessary for the introduction of verification strategy in Ukraine.
- Identify third-party software vendors to determine existing options and potential costs for implementing a third-party solution.
- Medicines Verification Landscape analysis in Ukraine, including examples from the neighboring countries, with the special focus on the European Union.
- Draft Ukraine National Medicines verification strategy and the implementation plan based on the key findings and recommendations of the Landscape analysis, including but not limited to the:
- Proposed implementation stages and the timeline with clear roles and responsibilities;
- Documentation for the establishment of the medicines verification working group and structure.
- High-level technical architecture, including the use of IT resources (internal, Ukrainian companies or non-Ukrainian companies).
- Documentation of all regulations and standards that need to be changed or added, including ownership and timelines.
- Document high-level MOH process changes necessary to implement medicine verification.
- Top line requirements and issues from Ukrainian government stakeholder as well as non-Ukrainian government stakeholders.
- Consolidated English-language technical report and a slide deck (landscape analysis, verification strategy, implementation plan and top-line requirements) including proposed recommendations, timelines and estimated cost.
- An outline of the Medicines Verification Pilot.
- Must be able to grasp the existing models for medicine registration, particularly the European (EMVO) model. System experience with bar codes, QR-Code and data matrix codes is valuable but not required.
- Experience working on complex projects. This effort requires coordinated efforts with several government agencies, health care facilities and commercial entities.
- Up to five years of experience with business process re-engineering and business requirements.
- Strong analytic skills are required, including the ability to synthesize and understand business issues to provide solutions.
- 4-5 years of experience architecting and implement web-based applications in a secure environment with high throughput and unreliable network availability.
- Strong communication and presentations skills.
- Strong project management skills and experience forming and operating working groups.
- Must be able to work independently.
- Good English language skills
Minimum educational level:
- Desirable education: Higher education in Economics or Higher education in Business management
Interested qualified candidates can send their CVs and motivation letter till January 18, 2019. Only shortlisted applicants will be contacted.