1 / 15

THIRD EAC STEERING COMMITTEE MEETING IMS TWG PROGRESS REPORT

THIRD EAC STEERING COMMITTEE MEETING IMS TWG PROGRESS REPORT. BUJUMBURA, BURUNDI 02/09/2013 TO 03/09/2013. OBJECTIVES OF THE IMS.

george
Download Presentation

THIRD EAC STEERING COMMITTEE MEETING IMS TWG PROGRESS REPORT

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. THIRD EAC STEERING COMMITTEE MEETINGIMSTWG PROGRESS REPORT BUJUMBURA, BURUNDI 02/09/2013 TO 03/09/2013

  2. OBJECTIVES OF THE IMS • To implement a common information management system for medicines registration/regulation in each of the EAC Partner States’ NMRAs which are linked in all partner states and EAC Secretariat. • Common information management system for drug registration/regulation operational in all EAC Partner States’ NMRAs and linked regionally by end of year 4

  3. ASSESSMENT • Assessment of EAC NMRAs done by WHO in February 2013. • Report was prepared and presented. • Report proposed • Architecture and infrastructure models for EAC NMRAs information systems

  4. FACE TO FACE MEETING - KIGALI • IMSTWG – met in Kigali in May and discussed the Assessment Report • The report was modified and a number of proposals adopted. These were: • IMS implementation architecture model was adopted. • Number of modules to be automated was agreed upon • A number of emerging issues were also noted. Some are: • System sustainability • Lack of a data sharing policy frame work • E-Readiness of countries and the EAC for automation • Availability of harmonised processes for automation

  5. VIDEO CONFERENCES • VCs were held and the IMSTWG developed documents addressing various issues. Documents primarily focused on: • System development process • IMS Architecture model • Specifications (VC equipment and IMS system) • Module to be automated • Business Processes Analysis (Medicines, Food, Cosmetics, Medical Devices, GMP, Import/Export)

  6. MILESTONES ACHIEVED • Documents developed by the IMSTWG are: • Assessment Report – • System Implementation Architecture • Modules for automation • Implementation Work plan • VC specifications • Request for Proposals • Software Specifications • Business Processes Analysis in: • Medicines • Food • Medical Devices • Cosmetics • GMP • Import/Export • Clinical Trials • Waste Management/Disposal

  7. PROPOSED SYSTEM DESIGN

  8. SUMMARY ON SYSTEM IMPLEMENTATION ARCHITECTURE • Currently we are in Circle B – Business Architecture • BPA has been done for various processes.

  9. RECOMMENDATIONS … 1 • The proposed developed system should be aligned to fit NMRA and EAC requirements (interoperability with other systems). • Information from TWGs in QMS, MER and GMP will be critical to the success of the IMS process and therefore current information dissemination process need review to factor in more: • Joint Face to Face meetings • Joint VCs

  10. RECOMMENDATIONS … 2 • Procurement of software development consultant to participate in the design, development, implementation and support of IMS system for each NMRA and the EAC through a process that will allow users participation, understanding and appreciation of the nature and impact of automation.

  11. RECOMMENDATIONS … 3 • Financial model for the development and implementation of the project needs to factor in: • Cyber Security • Hosting Services • User support and capacity building • Interoperability with other systems • None-infrastructure costs like e-readiness study • Change management issues.

  12. RECOMMENDATIONS … 4 • Bench marking of the IMS system with other international information systems used in Medicines regulation. • Need for legal guidance on issues regarding information sharing in the EAC partner states.

  13. RECOMMENDATION … 5 • Sustainability of the IMS project post implementation should focus on the areas of: • Human Resource (users) • Technology support (programmers and system administrators) • Finance (Licensing costs) • Training.

  14. FUTURE PROJECTIONS • The IMSTWG has only one projection. SUCCESS

  15. THANK YOU

More Related