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
If you are interested in learning about managing global regulatory projects, or perhaps you currently do work on global regulatory roll-outs, this article written for RAPS Regulatory Focus is for you.
Medicinal cannabis refers to a number of different forms of cannabis used for therapeutic purposes.