Accredited pharmacovigilance and regulatory affairs training designed for African professionals. We build real capability inside your organisation — not just compliance checkboxes.
Our training programmes are delivered by active pharmacovigilance and regulatory affairs practitioners. Every course is contextualised for African regulatory environments, with practical exercises drawn from real-world case scenarios. Completed courses include a verifiable digital certificate, and training records integrate directly with PV CompliSure for automatic compliance tracking.
What our training programmes deliver
Our programmes cover the full spectrum of pharmacovigilance and regulatory affairs competencies — from awareness-level induction through to advanced specialist skills.
Programmes available:
- Pharmacovigilance Fundamentals — foundation course for new and cross-functional staff
- ICSR Processing and MedDRA Coding — hands-on, case-based training
- Good Pharmacovigilance Practice (GVP) — Modules I–XVI, contextualised for Africa
- Signal Detection and Risk Management
- Aggregate Safety Reporting — PSURs, PBRERs, DSURs, PADERs
- Regulatory Affairs for African Markets
- Audit and Inspection Readiness — including mock inspection exercises
- Custom In-House Programmes — built around your SOPs and compliance gaps
Our training programmes in detail
Each programme is designed to build practical, applicable skills — not just theoretical knowledge. Our trainers are practitioners who work in pharmacovigilance and regulatory affairs every day.
Pharmacovigilance Fundamentals
The foundation course. What pharmacovigilance is, why it matters, the regulatory framework across Africa, and how PV systems operate in practice. Ideal for new team members, cross-functional staff, and non-PV personnel who interact with safety data.
ICSR Processing & MedDRA Coding
Hands-on training in case intake, triage, data entry, medical review, MedDRA coding (current version, full SOC/PT/LLT hierarchy), narrative writing, quality review, and regulatory submission — with live coding exercises using real-world case scenarios.
Good Pharmacovigilance Practice (GVP)
Module-by-module coverage of the GVP framework (Modules I–XVI), contextualised for African regulatory environments. Includes practical application guidance for each module.
Signal Detection & Risk Management
Quantitative and qualitative signal detection methods, benefit-risk assessment frameworks, Risk Management Plans (RMPs), and risk minimisation measures — for PV specialists and medical reviewers.
Aggregate Safety Reporting
How to plan, write, and review PSURs, PBRERs, DSURs, and PADERs. Covers data lock points, line listings, summary tabulations, and integrated benefit-risk analysis.
Regulatory Affairs for African Markets
Product registration, dossier preparation, post-approval variations, renewals, and regulatory strategy across NAFDAC and other African regulatory agencies — practical and market-specific.
Audit & Inspection Readiness
How to prepare for a pharmacovigilance audit or regulatory inspection, and how to perform well during one. Includes mock inspection exercises and CAPA preparation guidance.
Custom In-House Programmes
Bespoke training programmes designed around your products, SOPs, team structure, and specific compliance gaps. Delivered on-site at your premises, virtually, or through a blended learning approach.
Delivery formats & certification
We deliver training in the format that works best for your team — on-site workshops, live virtual sessions, self-paced e-learning through IntraHub LMS, or a blended combination.
On-Site & Virtual Delivery
On-site workshops at your premises or conference venue, live virtual sessions with interactive exercises, and blended learning programmes combining online and on-site elements.
Self-Paced E-Learning via IntraHub LMS
All courses are available through IntraHub LMS — our purpose-built learning management system with self-paced access, progress tracking, and automated compliance reporting.
Verifiable Digital Certification
All completed courses include a verifiable digital certificate. Training records integrate directly with PV CompliSure for automatic compliance tracking against your regulatory obligations.
Explore our catalogue or design a custom programme
Browse our full course catalogue on IntraHub LMS, or contact us to design a bespoke training programme for your organisation.
Our training is right for you if:
- You need to onboard new PV or RA staff quickly and consistently
- Your team requires GVP refresh training ahead of an inspection
- You want to build MedDRA coding capability in-house
- You are preparing for a NAFDAC pharmacovigilance inspection
- You need training records that integrate with your compliance system