Course
Introduction to Pharmacovigilance
A self-paced foundation course: PV regulations, case processing, signals, aggregate reports and risk management, for new PV professionals.
Resources and shop
Pharmacovigilance education
Courses, slide decks and documents written by a drug safety physician, for PV professionals, safety teams and companies building their PV capability.
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Course
Signal Management in Practice
Detection, validation, evaluation and documentation under GVP Module IX, with worked examples and templates.
Course
Benefit-Risk Assessment Fundamentals
How to structure, evidence and communicate benefit-risk evaluations across the product lifecycle.
Slide deck
Risk Management Plans and aRMMs: Training Deck
An editable training deck on EU RMPs, US REMS and additional risk minimisation, for in-house sessions.
Slide deck
Appraising Safety Evidence for Benefit-Risk Decisions
Slides on weighing data sources and the strength of safety evidence in benefit-risk decisions.
Slide deck
Aggregate Safety Reports: DSUR and PSUR/PBRER Essentials
The purpose, structure and key messages of DSURs and PSURs/PBRERs.
Document
PV Inspection Readiness Checklist
A structured checklist covering PSMF, quality system, SOPs, training records and inspection-day logistics.
Document
Signal Evaluation Report Template
An annotated template for documenting signal assessments consistently.
Bundle
PV Starter Toolkit for Biotechs
Templates and checklists for companies setting up their first pharmacovigilance system.
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Training for your team
I also deliver in-house PV training and team licences for the courses.