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Regulator Interactions

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

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.

Research enough

Isn’t my research enough? – Success amongst the learnings

Commercialising medical research has its challenges, refer to my previous two articles which share some of the challenges, and offer some helpful resources. And “challenges” isn’t code for ‘a little tricky’ – it is estimated that only 9.6% of medicines in Phase I clinical trials actual progress to US FDA approval[1]. And

Helpful resources

Isn’t my research enough? – Helpful resources

In my previous article, Isn’t my research enough? – Translational research meets Commercialisation,  I shared with you some of the challenges in moving beyond research to commercialised outcomes for patients. What I would like to do in this article is help you navigate some of the important stakeholders (of course, there