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How has the COVID-19 pandemic impacted Regulatory professionals?

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

BiologicALs vs Biologics – two letters to FMT

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 new online learning in Regulatory Affairs

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.

Regulator Interactions During COVID-19

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

Global Regulatory Projects: Best Practices

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.