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Blog Articles08 Feb 2024
The Year of the Dragon stands as a fitting emblem for Hong Kong’s medicines regulatory system, symbolising strength, resilience, and vigilant...
Blog Articles05 Mar 2021
Recent changes in TGA Medical Device Regulations In December 2020, TGA released a new Personalised Medical Device Guideline along with a suite of new names and definitions that have shaken up...
Blog Articles28 Jan 2021
Is Artificial Intelligence Becoming Too Smart for Regulators? AI is Everywhere and it isn’t that New! The term ‘artificial intelligence’ (AI) was first coined in the 1950s. Since then, this disruptive...
Blog Articles26 Nov 2020
The long-awaited transition to the EU Medical Devices Regulation (MDR) is looming. The regulatory realm of medical devices is in a state of flux and poised on the brink of the...
Blog Articles15 Oct 2020
Australian science and technology sectors are talking about a ‘research revival’ as the Federal Government splashes the cash in the 2020 Budget. 2020 Budget Cash Splash Thanks to COVID-19, early October...
Blog Articles20 Mar 2020
By now, we should all be very familiar with the new Form for providing Product Information (PI) for Australia. Each time you make a change to a PI, be it safety-related...
Blog Articles11 Mar 2020
We may have a global market but do we really consider options outside of USA and EU when developing our Therapeutic Product Commercialization strategy? The USA, EU/UK are large markets with...
Blog Articles14 May 2019
Today, we are pleased to introduce one of our affiliates and guest blogger, Anna Pannuzzo from WorkPlacePLUS. In this post, Anna discusses some key workplace health, safety and other legal aspects...
Blog Articles18 Jan 2019
If you’re advertizing therapeutic goods in Australia in 2019, there’s new legislation that is critical to your successful campaign/s.
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