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Use of NDS v 6: South Africa Experience

Learn about the transition from manual to electronic systems in the South African Medicines Regulatory Authority. Explore the impacts on accuracy, efficiency, and compliance through the NDS V.6 implementation.

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Use of NDS v 6: South Africa Experience

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  1. Use of NDS v 6: South Africa Experience Rina Schoeman Medicines Regulatory Authority Department of Health South Africa 6-8 May 2007

  2. Medicine Regulatory AuthoritySouth Africa

  3. Functions of Inspectorate & Law Enforcement

  4. Use of NDS v 6: South Africa ExperienceBefore 2005 • Manual system / local • Time consuming • Calculation errors • Number of come backs from INCB requesting clarification

  5. Use of NDS v 6: South Africa Experience2005: NDS v 5.2 • Load system June 2005 • Pilot run for 6 months • Positive feedback on system: • Accuracy increased • Turn around times increased • Planning increased • Number of permits handled increased • Man-hours needed decreased

  6. Use of NDS v 6: South Africa Experience2006 Fully implemented NDSv5.2 • Fully implemented program • Little errors • Work load manageable • Number of come backs from INCB requesting clarification minimum

  7. Use of NDS v 6: South Africa Experience2006 December NDSv6.1 • Fully implemented program • Quarterly reports 2006/2007 submitted timeously • Identified migration of data problematic • Minor errors • Discussion with UNODC on data migration

  8. Use of NDS v 6: South Africa ExperienceWAY FORWARD • Available Electronic Document Management of unendorsed permits • Electronic Document Management with Applicants and other Stakeholders

  9. Rina Schoeman Directorate: Inspectorate and Law Enforcement schoer@health.gov.za

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