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