SAPRAA 2009 Presentations


November 2009


PPTA glimpse of what SAHPRA is intended to become(861 KB PPT)


A survey of volumes of antibiotics used in food animals in South Africa from 2002 to 2004(2.16MB PPT)


PPTConsumer Protection Act 68/2008(263KB PPT)


PPTDiabetes Mellitus(2.66MB PPT)



September 2009


PPTIntellectual Property within the Pharmaceutical Industry (812 KB PPT)


PPTDru Stakeholders' workshop (771KB PPT)


PPTStrategic health plan and anticipated changes to MRA/MCC (229KB PPT)


PPTHI/N1 Pandemic(5.12MB PPT)


PPTContinuing Professional Development(3 MB PTT)



DRU Proposed Guidelines (PDF)


PDFGuidance for Industry - Bioanalytical Method Validation


PDFBiowaiver Application form


PDFBotswana check list for variations


PDFBotswana guidelines for stability studies


PDFGuidelines on Bioavailability and Bioequivalence


PDFBotswana Guidelines on Good Manufacturing Practices


PDFBotswana variation application form


PDFClinical trails guidelines


WordDraft guideines discussed at the DRU workshop(Word)


PDFDossier requirements for variations


PDFGuidelines on drug registration applications in Botswana


PDFImpuriries in new drug products


PPTPharmaceutical development


PDFQualification and validation EMEA


PDFValidation of analytical procedures




June 2009


PPTOsteoporosis - Dr Mampedi Bogoshi(3.24 MB PPT)


PPTPharmaceutical Quality Systems (ICH Q10) Concepts & Implementation(6.12 MB PPT)


PPTSWITCHING OF MEDICINES (5.8 MB PPT)


PPTPharmaco Vigilance(1.1 MB PPT)


PPTGUIDELINES FOR THE RESCHEDULING OF MEDICINES(281 KB PPT)


PPTSAPRAA MEETING (56 KB PPT)



March 2009


WordOverview of SAPRAA Activities 2008(41.5KB Word)


WordSAPRAA AFS (117KB Word)


PPTQuality Risk Management (1.8MB PPT)


PPTBioequivalence Studies (2.81MB PPT)


PPTQuality Risk Management Methodology (5.85MB PPT)


PPT World Health Organization Activities Focus on Prequalification of Medicines (2.81MB PPT)