Pharmacovigilance
Practical perspectives on drug safety, signal management, and post-marketing oversight.
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MedNova shares practical regulatory, pharmacovigilance, clinical development, and scientific knowledge for life sciences organizations working across Nigeria and Africa.
Browse practical guides, glossary definitions, and the NAFDAC QPPV Compliance Checklist — or download the checklist PDF — to connect safety, regulatory, and trial readiness. See glossary definitions for adverse drug reaction, Good Pharmacovigilance Practice, and Risk Management Plan. If you want help applying these insights, explore our training and consulting services.
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Our resources are designed to support teams with clear guidance, real-world examples, and actionable insight.
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Medical Writing
Support for scientific, clinical, and regulatory content development.
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Clinical Development
Guidance on trial readiness, operations, and regional delivery.
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Regulatory Affairs
Insights on strategy, registration readiness, and regulatory planning.
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Change Briefs
A practical framework for turning regulatory changes into controlled implementation steps and evidence-based follow-through.
Drug Safety
Articles and practical guidance on safety operations and reporting readiness.
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NAFDAC
Local market insight and guidance for registration and compliance planning.
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Clinical Research
Approaches to readiness, documentation, and operational execution.
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QPPV Support Essentials
Practical guidance for QPPV oversight, documentation, vendor control, and strong pharmacovigilance accountability.
Clinical Research: Site Readiness
A practical guide to feasibility, delegation, facilities, documentation, and activation readiness for clinical trial sites.
PV Readiness Guide
An operational guide to governance, case handling, signal review, and inspection preparedness for PV teams.
NAFDAC PV Requirements
A complete breakdown of NAFDAC's Good Pharmacovigilance Practice guideline: QPPV rules, the master file, reporting duties, and a compliance checklist.
After You Report to NAFDAC
What happens to an adverse event report after submission: ICSR validation, follow-up requests, signal detection, and what triggers regulatory action.
GVP Compliance in Nigeria
A plain guide to what GVP compliance actually means: the pharmacovigilance system, the resident QPPV, qualified personnel, and a full compliance checklist.
Glossary
Search a growing reference library of life sciences terminology for pharmacovigilance, regulatory affairs, clinical development, and medical writing.
Includes glossary definitions for Medical Information and Medical Writing.
QPPV in Nigeria
Explore the role of QPPV support in pharmacovigilance readiness, local oversight, and governance alignment.
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Latest Resources
Current articles and updates
What Is GVP Compliance?
A plain guide to what GVP compliance actually means for Nigerian pharma companies: the pharmacovigilance system, the resident QPPV, qualified personnel, and a full checklist.
What Happens After You Report an Adverse Event to NAFDAC?
A step-by-step walkthrough of NAFDAC's adverse event review process: ICSR validation, follow-up requests, signal detection, and what triggers regulatory action.
NAFDAC Pharmacovigilance Requirements
A plain language breakdown of NAFDAC's pharmacovigilance guideline, covering the QPPV, the master file, reporting duties, common compliance gaps, and a full checklist.
Clinical Development
A practical guide to clinical development concepts, study design, feasibility, ethics, and operational execution.
Clinical Development Readiness
A practical article on regional trial readiness and the realities of executing clinical programs in Nigeria and West Africa.
Regulatory Affairs
A practical primer on regulatory strategy, dossier quality, labelling, lifecycle control, and governance for pharmaceutical companies operating in Nigeria and Africa.
Regulatory Change Briefs
A practical guide to assessing new regulatory developments, prioritising risk, and implementing controlled action across local and regional teams.
NAFDAC Product Registration
A practical guide to product registration in Nigeria, including classification, local representation, dossiers, timelines, inspections, and post-registration obligations.
Registration Preparation Guide
A practical overview of dossier readiness, reliance pathways, timelines, labelling, and submission coordination for NAFDAC market-entry programmes.
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Future content we are preparing
Medical Writing
Writing Effective Clinical Study Reports