SAPRAA 2009 Presentations

November 2009

A 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)

Consumer Protection Act 68/2008(263KB PPT)

Diabetes Mellitus(2.66MB PPT)

September 2009

Intellectual Property within the Pharmaceutical Industry (812 KB PPT)

Dru Stakeholders' workshop (771KB PPT)

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

HI/N1 Pandemic(5.12MB PPT)

Continuing Professional Development(3 MB PTT)

DRU Proposed Guidelines (PDF)

Guidance for Industry - Bioanalytical Method Validation

Biowaiver Application form

Botswana check list for variations

Botswana guidelines for stability studies

Guidelines on Bioavailability and Bioequivalence

Botswana Guidelines on Good Manufacturing Practices

Botswana variation application form

Clinical trails guidelines

Draft guideines discussed at the DRU workshop(Word)

Dossier requirements for variations

Guidelines on drug registration applications in Botswana

Impuriries in new drug products

Pharmaceutical development

Qualification and validation EMEA

Validation of analytical procedures

June 2009

Osteoporosis - Dr Mampedi Bogoshi(3.24 MB PPT)

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

SWITCHING OF MEDICINES (5.8 MB PPT)

Pharmaco Vigilance(1.1 MB PPT)

GUIDELINES FOR THE RESCHEDULING OF MEDICINES(281 KB PPT)

SAPRAA MEETING (56 KB PPT)

March 2009

Overview of SAPRAA Activities 2008(41.5KB Word)

SAPRAA AFS (117KB Word)

Quality Risk Management (1.8MB PPT)

Bioequivalence Studies (2.81MB PPT)

Quality Risk Management Methodology (5.85MB PPT)

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

				2019