If you sponsor medicines in Australia, appointing a local Pharmacovigilance Contact Person isn’t…
Master pharmacovigilance audit methodology from strategic planning through CAPA close-out. This comprehensive guide…
Why AI projects “fail” to deliver ROI: pilots aren’t production, ROI isn’t defined,…
ICH GCP E6(R3) clinical trial modernisation: design quality in, control risk, and prove…
Human-in-the-Loop defines who owns AI-driven regulatory decisions. Learn where regulators require human validation,…
ICH E6(R3) transformed computer system validation from IT documentation to mandatory GCP accountability.…
A practical guide to 21 CFR Part 11 compliance—covering electronic records, audit trails,…
How the draft PIC/S Annex 22 AI GMP guidance reshapes validation, oversight, and…
Australian pharmaceutical sponsors must maintain full TGA compliance throughout the December–January shutdown. This…
This article explains how to develop a compliant Australian-Specific Annexure (ASA) that aligns…
Navigating 2026 ICH E6(R3) Implementation in Australia: Your Quality Management Transformation Guide
Introduction When did your monitoring team last anticipate and prevent a protocol deviation?This…
The modern Australian QPPV in 2026 faces an environment transformed by AI, evolving…