Course Overview
An intensive 5-day workshop for pharmaceutical professionals covering the full regulatory affairs landscape for medicine registration in Namibia (NMRC) and South Africa (SAHPRA). Delegates learn dossier preparation to CTD/eCTD format and regulatory submission strategies.
Topics include complementary medicine registration, medical device regulation, generic applications, and post-market surveillance. Ideal for regulatory affairs officers, quality managers, and pharmaceutical industry professionals.
Who Should Attend?
Regulatory affairs officers
Quality assurance pharmacists
Pharmaceutical industry professionals
Pharmacists transitioning to regulatory affairs
Medicine importers and distributors
Complementary medicine manufacturers
Course Outline
| # | Module / Unit | Key Topics |
|---|---|---|
| 1 | Regulatory Environment Overview | NMRC, SAHPRA legislation, Medicines Act, harmonisation |
| 2 | Medicine Classification & Types | Prescription, OTC, complementary, veterinary, devices |
| 3 | CTD/eCTD Dossier Structure | Quality, safety, efficacy modules; module content requirements |
| 4 | Quality Module (Module 3) | API specifications, finished product, stability, GMP |
| 5 | Non-Clinical & Clinical Data (Modules 4 & 5) | Bioequivalence, clinical study summaries, literature |
| 6 | Complementary Medicine Registration | SAHPRA complementary framework, Category A–D |
| 7 | Medical Device Regulation | Risk classification, technical files, post-market surveillance |
| 8 | Submissions, Fees & Timelines | Application process, common deficiencies, scheduling appeals |
| 9 | Post-Market Surveillance | Pharmacovigilance, SAE reporting, product recalls |
| 10 | Workshop Case Studies | Group dossier exercise, regulatory Q&A, mock submissions |
Entry Requirements
- Pharmacist, pharmacy graduate, or science graduate
- Experience in pharmaceutical industry advantageous
- Basic knowledge of drug development beneficial
- Open to regulatory support staff with relevant experience
