October 17, 2024
Navigating TGA Pathways for Prescription Medicines in Australia: A Brief Overview
Standard Pathway Is the traditional route for registering prescription medicines in Australia, irrespective of whether your medicine is a new
April 20, 2021
What I’ve learnt from preparing Regulatory Strategies Part 1 – 3
Part 1 What I’ve learnt from preparing Regulatory Strategies - before you begin
October 21, 2020
How has the COVID-19 pandemic impacted Regulatory professionals?
Last week I had the pleasure of chairing a Regulatory Managers panel discussion where we discussed this topic. How many of
August 29, 2020
BiologicALs vs Biologics – two letters to FMT
Australia’s Therapeutic Goods Administration (TGA) announced earlier this year that Faecal Microbiota Transplant (FMT) would be regulated as biologicALs. Yet,
August 27, 2020
Introducing new online learning in Regulatory Affairs
Introducing a very different type of on-line learning in Regulatory Affairs. Flexible and engaging, tutorial access over six or nine months,