Successfully registering a new prescription medicine in Australia requires a deep understanding of the Therapeutic Goods Administration (TGA) approval process. Whether you are bringing a novel treatment to market or submitting a generic version of an existing therapy, choosing the right pathway is essential. Below is a streamlined overview of
Part 1 WHAT I’VE LEARNT FROM PREPARING REGULATORY STRATEGIES – BEFORE YOU BEGIN…. So you’ve been asked to prepare a regulatory strategy… good for you! You’ve been given an opportunity to contribute at a higher level and demonstrate how you bridge your technical expertise with your organisation’s drivers. Though consider yourself warned
Last week I had the pleasure of chairing a Regulatory Managers panel discussion where we discussed this topic. How many of these key messages resonate with you? The U in VUCA– be comfortable with a level of Uncertainty as Uncertainty is unavoidable – in fact, one can even say it is
Australia’s Therapeutic Goods Administration (TGA) announced earlier this year that Faecal Microbiota Transplant (FMT) would be regulated as biologicALs. Yet, many biologically-derived medicines are regulated as what we tend to call biologics. So how do two letters distinguish between two regulatory pathways, and how to remember the difference? BiologicALs vs Biologics - two letters
Introducing a very different type of on-line learning in Regulatory Affairs. Flexible and engaging, tutorial access over six or nine months, and with the option to complement the learning with mentoring and a Certificate of Completion.
How have you managed your interactions with Regulators during this COVID 19 environment? I am excited at the level of research and development occurring around the world aimed at therapeutic interventions for COVID-19. It is easy to forget that Regulators are working through altered work environments which come with the social