APW for on online registration system of pharmaceutical products
BACKGROUND
The Department of Drugs, Food and Cosmetics (DDF) is a semi-autonomous agency under the Ministry of Health with a mandate of ensuring that all medical products are subjected to appropriate regulatory control in order to protect the health of the public. Each medical product including multisource (generic) medicines in the Cambodian market must comply with acceptable standards of quality, safety, and efficacy. They require regulatory approval by DDF prior to marketing through the process of medicine registration (i.e. marketing authorization).
A review of the business processes was conducted at Department of Drugs and Food for Registration with the view of mapping the processes involved for marketing authorization so as to enable development of online medicine registration system. The online registration system has been developed based on registration flow charts since April 2018.
PURPOSE AND DESCRIPTION OF ACTIVITIES TO BE CARRIED OUT
In close collaboration with the WHO Country Office in Cambodia and under direction of the National Regulatory Authority, an experienced contractor will be required to provide support for finalization, launching and implementation as well as maintenance of the online (web-enabled) registration system of health and pharmaceutical products at the Drug Registration Bureau, Department of Drugs and Food (DDF), Ministry of Health, Kingdom of Cambodia. Tasks under this contract build on previous and continuing work on streamlining procedures and plans on strengthening the registration system of DDF.
The activities to be carried out would include:
- Finalize a complete set of the software for registration of various health and pharmaceutical products which include modern medicines, traditional and complementary medicines, and medical devices as well as cosmetics
- Provide the strategy, guide and documents for maintenance:
- server maintenance (physical server)
- system maintenance (online registration portal system); and
- work-flow maintenance for internal users
- code level maintenance
- code change impact analysis
- any support required to maintain the codes making sure system works as intended.
- Provide the data migration strategy including:
- data migration from the old system to the new system,
- support database mapping documentation
- Provide training material for each stakeholder including:
- manual for internal stakeholders (regulators and server providers)
- manual for external stakeholders (applicants)
- workflow level maintenance
- workflow change impact analysis and
- any support on change management in the workflow
- Provide payment workflow strategy
- Provide server communication maintenance:
- security aspect of the communication layer
- establishing & monitoring the secure server link
- support ticket system for technical support ( which are easy to use technical ticketing system and easy to use non-technical ticketing system).
- Provide onsite training to users which will be done separately to:
- regulators
- applicants
- ministry of Communication on providing server and portal system implementation support
A detailed plan will be discussed with a selected contractor.
- Develop a plan for training of users and hand-over the system to the national regulatory agency
- Provide IT maintenance support for a period of one year from the system launch.
- Submit a package of documents and manuals as required along with a technical report.
METHODS TO CARRY OUT THE ACTIVITY AND LIST OF OUTPUTS
Finalization of the online registration system, training of end-users, development of user manuals and guidelines and provision of online IT support.
Method(s) to carry out the activity
system analysis and design, training of end-users, development of user’s guide and manuals, consultation with users, trouble-shooting, remote support
Output/s
The following deliverables of the assignment have been identified and will be tied to the release of funds.
Output 1: Complete the software for registration of various health and pharmaceutical products
Deliverable 1: modern medicines and biologicals
Deliverable 2: modern medicines, traditional and complementary medicines,
Deliverable 3: medical devices
Deliverable 4: cosmetics
Output 2: Booklet of guidelines and documents for:
Deliverable 1: server maintenance (physical server)
Deliverable 2: system maintenance (online registration portal system)
Deliverable 3: work-flow maintenance for internal users
Deliverable 4: code change impact analysis
Deliverable 5: data migration from the old system to the new system and support database mapping
Deliverable 6: system adaption document for the payment workflow management.
Output 3: Manual:
Deliverable 1: internal stakeholders (regulators and server providers)
Deliverable 2: external stakeholders (applicants)
Deliverable 3: workflow level maintenance & workflow change impact analysis
Deliverable 4: server communication and trouble-shooting
Output 4: Training and hand-over
Deliverable 1: plan for training of users and
Deliverable 2: hand-over the system to the national regulatory agency
Output 5: Final report
Deliverable 5.1 final report which includes all the deliverables stated above.
QUALIFICATIONS & EXPERIENCE
EDUCATION
Essential: University degree or higher in computer science or related field from a recognized institution or international professional certificate in a software developing language
Desirable: training on health informatics or regulatory affairs
EXPERIENCE
Essential: at least 5 years of proven experiences in web technologies and information systems including their development and deployment. Extensive experience and knowledge in Secure web portal development (Java, Javascript), HTML5, XML, JWT security and open source content management systems software. Proven database programming with oracle database. Proven experience in working with medicines regulatory authorities.
Desirable: developing and managing database and system within medicines regulatory authority in resource-limited settings.
TECHNICAL SKILLS & KNOWLEDGE
- Excellent understanding of regulatory framework
- Excellent knowledge in pharmaceutical legislation
- Excellent communication and presentational skills
- Ability to work effectively with government counterparts from various sectors/ministries, stakeholders from public and private sectors.
LANGUAGES
Excellent English written and oral communication skills
COMPETENCIES
- Good understanding of the Linux hosting environment
- Good understanding of Open standards for web portal development and implementation.
ADDITIONAL INFORMATION:
Planned timelines (subject to confirmation)
DUTY STATION: Phnom Penh, Cambodia
ORGANIZATION: WHO Western Pacific Regional Office
TYPE OF CONTRACT: Agreement for Performance of Work (APW)
APPLICATION DEADLINE: 17 June 2019
STARTING DATE: 17 June 2019
DURATION OF CONTRACT: 9 months and half (17 June 2019- 30 March 2020)
A detailed workplan plan will be discussed with a selected contractor.
Place of assignment
The assignment will be remote desk-based work supported by videoconferences.
Medical clearance
N/A
Travel
The contractor is expected to travel to Phnom Penh at least three times during the course of the contract to provide onsite trainings to end-users and server/system administrators.
APPLICATIONS
Qualified and interested specialists should submit their CV {for individual contractors} or Company Profile (including CVs of IT experts and Detailed Technical proposal and budget estimate ) {for institutional applications} and Expression of Interest {cover letter} and financial proposal on a monthly and daily rate in USD to the Supply Officer through WP RO UNGM at < wproungm@who.int > by 17 June 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 fee and availability.
Please use Tender Notice No. WPRO/2019-06/KHM_PHA/TN91693/vrs as subject to all submission. Only successful candidates will be contacted.