Standard Pathway Is the traditional route for registering prescription medicines in Australia, irrespective of whether your medicine is a new chemical or biological-derived medicine), a biosimilar medicine, or a generic medicine. Whist it might take longer than some of the expedited options it remains a robust and thorough process, and
Part 1 What I’ve learnt from preparing Regulatory Strategies - before you begin
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