Presentations 2011

 

November 2011

Feedback from SAPRAA Workshop with PPB (108KB PPT)

Practical Antiretroviral Medications in Paediatrics (3.32MB PPT)

The 'Ripple' Effect Tales (137KB PPT)

The New Kenyan Drug Regulation Guidelines (1.92MB PPT)

 

September 2011

Continuing Professional Development (903KB PPT)

Pharmacy Week 2011 Towards: Quality Care Together (1.02MB PPT)

CAMS in South Africa (5.69MB PPT)

ZA CTD practical application – some Do's & Dont's (2.32MB PPT)

Comprehensive Table of Contents (21.9KB Word)

 

June 2011

The Consumer Protection Act Pharmaceutical Industry ‐ Updates (164KB PDF)

Feedback from SAAPI Pharmacovigilance Workshop held on 24 May 2011 (384KB PDF)

Consumer Protection Act: A Legal Perspective (301KB PDF)

Drug Regulatory Unit: Botswana (2.1MB PDF)

Feedback from RA Workshop: Botswana DRU (8.21MB PDF)

 

April 2011

Feedback from: Workshop held to discuss Namibia Medicine Regulatory Council Requirements (3.14 MB PDF)

The South African Medical Device Industry Association (336KB PDF)

Pharmaceutical Control & Inspection (136KB PDF)

Medical Device Regulations: Update and SAMED’s position (808KB PDF)

Namibia Medicines Control Act (113KB PDF)

Fees payable to the registrar (40KB PDF)

Proposed NMRC Meeting dates 2011 (20KB PDF)

 

Presentations 2010

November 2010

ACTIVATE and ENERGISE your best you! (2.11 MB PPT)

Biosimilars Guideline – a Summary of the Industry Commenta (1.18 MB PPT)

ZA CTD (688 KB PDF)

SA Code of Practice for the Marketing of Health Products (1.35 MB PPT)

 

September 2010

CTD/eCTD guidelines PIASA’S comments (105 KB PDF)

SAPRAA Agenda (25 KB PDF)

Regulatory requirements for the ZA CTD (299 KB Word)
This document is password protected. Please click on “read only” and save it under a different name if they want to edit the information for their own use.

Regulatory Requirements for the ZA CTD (123 KB PDF)

Comprehensive table of Contents (44 KB PDF)

Dossier product batch information (14 KB PDF)

Dossier batch Information (23 KB PDF)

Screening and Technical Verification Template (83 KB PDF)

The ZA CTD (3.22 MB PDF)

Preparing for the CTD (and more) - Michael S. Schultz (411 KB PDF)

 

 

June 2010

Feedback on MCC Project meeting held on 14 May 2010 (213 KB PPT)

Ethics and Compliance (2.19 MB PPT)

Draft SA Marketing Code (1.61 MB PPT)

 

 

March 2010

Financial Statements (33.7 KB PDF)

SAPRAA Activities 2009 (541 KB PDF)

eCTD: Industry Experience (323 KB PDF)

2nd African Regulatory Conference:KEY TAKEAWAYS (2.15 MB PDF)

Malaria (2.03 MB PDF)

The ideal clinical submission (109 KB PDF)

Stability testing conditions of pharmaceuticals (3 MB PDF)

 

Presentations 2009

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 ActivitiesFocus on Prequalification of Medicines (2.81MB PPT)

 

Presentations 2008

November 2008

EDMS Workflow Specification and Software Configuration Project Update (4.67MB PPT)

Configuration Management (632KB PPT)

 

 

September 2008

Hyperlipidemia (4.23MB PPT)

Save Disposal of Medicine and Medical Waste (434KB PPT)

NEW NAMIBIA MEDICINES CONTROL ACT (70KB PPT )

eCTD (200KB PPT)

Namibia Act 1 (PDF)

Nambia Act 2 (PDF)

INCENTIVES FOR INVESTORS AND EXPORTERS (278 KB)

Registrar of Medicines & Pharmaceutical Industry (1.57 MB)

MINUTES OF THE MEETING BETWEEN
THE OFFICE OF THE REGISTRAR OF MEDICINES: MEDICINES REGULATORY AFFAIRS AND THE PHARMACEUTICAL INDUSTRY (70Kb Word)

Meeting with the SA Pharmaceutical Industry Department of Health (551 KB)

 

June 2008

FEEDBACK ON AFRICA REGULATORY CONFERENCE (294 KB PPT)

Latest in Health Law…. (139 KB PPT)

INCB PERMITS & REQUIREMENTS FOR ESTIMATES (384 KB PPT)

SCHEDULING OF MEDICINES (596 KB PPT)

 

March 2008

ANNUAL FINANCIAL STATEMENTS (70 KB Word)

GMP Auditor and Report Writer (292 KB PPT)

Meeting fee 2008 - Hilde Rodseth (44KB PPT)

PACKAGE INSERTS FOR HUMAN MEDICINES (212 Kb Word)

GUIDELINE ON INFORMATION FOR THE INDUSTRY COMMENTS ON PACKAGE INSERTSGUIDELINES - Dr Dorcas Peta (59.5 Kb PPT)

Allergy - Mark Hopley (2.46MB)

 

 

 

S A Pharmaceutical Regulatory Affairs Association P O Box 2909 Randburg 2125 R.S.A. Telephone: (011) 886 1075 Telefax: (011) 392 4144