2023 – Presentations
2022 – Presentations
June
2021 – Presentations
Financial Statements
April
August
2020 – Presentations
2019 – Presentations
2018 – Presentations
August
- Common Quality Aspects To Consider For New Applications Davis Mahlatji
- Clarification With Respect To A Stringent Regulatory Organization As Applicable To The Stringent Regulatory Authority (SRA) Guideline
- BOMRA SAPRAA August 2018 Questions & Answers
- Status Updates On The NHI Mr Sham Moodley
- SAPRAA AGENDA
- Latest Developments BOMRA Dr Ghanie & Dr Selelo
- Counter Anti Vaccination Myths And Build The Vacci(Nation) Prof HJC Meyer
2017 – Presentations
2016 – Presentations
April
- 2016 Update SAPC TA Masango
- The Power Of The Collective Jennifer Power
- Medical Device Regulatory Road Map (SAMED Conference) Dr Joey Gouws
- Latest Gazetted Regulation MCC Guidelines Concerns And Comments By SAMED Tanya Vogt
- Dynamic Legislative Change Expected Elsabe Klinck
- Consolidated Text Of Medicines And Related Substances Act No. 101 OF 1965
August
- ECTD Practical Experiences Of The ECTD Pilot Project And Way Forward Estelle Taute
- 17th ICDRA Presentation Andrea Julsing
- Update From The IGDRP Biowaivers Working Group Dr. Craig Simon
- Polio And Its Eradication Initaitives Prof (Emeritus) MJ Matjila
- IGDRP Quality Working Group (WG)
- IGDRP – Mission, Scope, How It Works Dr. Craig Simon
- Feedback On SADC Workshop Of Industry & Regulators Luther Gwaza
2015 – Presentations
June 9 July 2015 Skills Dialogue in SA Pharma - Post Forum Report
2014 – Presentations
2013 – Presentations
2012 – Presentations
March
- MCC CEPT As Per Guidelines
- MCC AS EXAMPLE PERFECT CURE 500 Mg
- MCC Appendix A2 Example
- MCC API Report Of Comparative Study
- MCC Amendment Submissions Format
- MCC 32R141 Pharmaceutical Availability Studies
- MCC 2.25 PA CTD Jun11 V3
- MCC Contact Information
- Feedback On Industry Meeting With Nichloas Crisp
- ARC Flyer
- SAPRAA Financial 2012
- MCC Za Ctd 9 Months Later
- MCC TOC Working Doc
- MCC PERFECT CURE 500 Mg CTOC EXAMPLE
- MCC PART B Module 1
- MCC EXAMPLE PRODUCT, 12345 CTD Update
- MCC EXAMPLE PHARMACEUTICALS Cover Page Of Submission
- MCC Example Pharma Pty Ltd
- MCC EXAMPLE APPLICATION FORM
- MCC CTD Vs MRF1 Vs MBR1
- MCC CTD Stability Data
- MCC Cover Letter Section 6
- MCC Comprehensive TOC
November
- Update On Regulatory Developments Around The ECTD In Europe And The Quantum Leap Ahead For South Africa
- Sequence Master Outline
- Pharmacodynamics & Pharmacokinetics PI And PIL Considerations
- Organisation Of The Common Technical Document For The Regsitration Of Pharmaceuticals For Human Use M4
- International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuteicals For Human Use
- Forecasted Guideline Changes
- ECTD Next Major Release Business Requirements Collation
- Current Master Outline
2011 – Presentations
April
- The South African Medical Device Industry Association
- Proposed NMRC Meeting Dates 2011
- Pharmaceutical Control & Inspection
- Namibia Medicines Control Act
- Medical Device Regulations Update And SAMED’s Position
- Fees Payable To Registrar Namibia
- Feedback From Workshop Held To Discuss Namibia Medicine Regulatory Council Requirements
2010 – Presentations
2009 – Presentations
September
- Botswana Guidelines For Stability Studies
- Botswana Check List For Variations
- Biowaiver Application Form
- Validation Of Analytical Procedures
- Strategic Health Plan And Anticipated Changes To MRA MCC Dr. Gouws
- Qualification And Validation EMEA
- Pharmaceutical Development
- Intellectual Property Within The Pharmaceutical Industry
- Impurities In New Drug Products
- H1N1 Pandemic Prof Barry Schoub
- Guidelines On Drug Registration Applications In Botswana
- Guidelines On Bioavailability And Bioequivalence
- Guidance For Industry Bioanalytical Method Validation
- DRU Stakeholders’ Workshop Liz Filby
- Draft Guideines Discussed At The DRU Workshop
- Dossier Requirements For Variations
- Continuing Professional Development
- Clinical Trails Guidelines
- Botswana Variation Application Form
- Botswana Guidelines On Good Manufacturing Practices