PvSentinel Articles
Practical guidance on pharmacovigilance compliance and safety reporting for MAHs, QPPVs, and LTRs in Kenya and East Africa.
MAH vs LTR: Pharmacovigilance Responsibilities in Kenya
How responsibilities split between a Marketing Authorization Holder and its Local Technical Representative for pharmacovigilance compliance in Kenya.
Data Protection in Pharmacovigilance: DPA 2019 & Digital Health Act
How Kenya's Data Protection Act 2019 and Digital Health Act 2023 intersect with pharmacovigilance data handling, and what MAHs need to consider.
PPB Pharmacovigilance Audit Checklist for Kenyan MAHs
What PPB inspectors look for during a pharmacovigilance audit, and a practical checklist to prepare your MAH or LTR for one.
Literature Surveillance for Pharmacovigilance in Kenya
Why literature monitoring is a core PPB pharmacovigilance requirement, what it involves, and why manual literature screening doesn't scale.
Signal Detection in Pharmacovigilance: A Guide for Kenyan MAHs
What signal detection means in pharmacovigilance, the statistical methods behind it, and why it's becoming a PPB expectation for MAHs.
Cost of PV Outsourcing in Kenya: In-House vs Outsourced vs Software
Comparing the real cost of in-house QPPV hiring, outsourced PV/QPPV-as-a-service, and software-led compliance for Kenyan MAHs.
Setting Up a PV System in Kenya: Timeline & Requirements
What it actually takes to build a PPB-compliant pharmacovigilance system from zero — the six components, typical timeline, and common pitfalls.
How to Report ADRs via PvERS in Kenya
A step-by-step guide to submitting adverse drug reaction reports through PPB's PvERS system, including serious vs non-serious ADR timelines.
PPB PSUR Submission Requirements & Timelines
PSUR and PBRER submission timelines under PPB rules — 6-monthly, annual, and 3-yearly cycles explained, plus what happens if you miss one.
QPPV Requirements in Kenya — Who Qualifies?
What Kenyan MAHs need to know about QPPV requirements under PPB rules — qualifications, responsibilities, and common compliance mistakes.