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Incorporating patients’ voices in the drug development process

Post thumbnail Incorporating patients’ voices in  the drug development process

Our Senior Director, Mike Day recently interviewed Robyn Bent, Director, CDER PFDD Program, Center for Drug Evaluation and Research, US FDA, on behalf of TOPRA.  In this interview, Robyn Bent talked about the Patient-Focused Drug Development Program, patient engagement and the lessons learnt so far from the COVID-19 pandemic. She also shared some advice on the preferred or most successful methodologies to engage with patient groups, as well as highlighting the risks today for the companies who have not engaged with patients groups before interacting with the FDA.


Published on: Sep 23, 2020 
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    publication by

    Mike Day
    Michael Day, PhD
    Senior Director, Regulatory Science
    As Senior Director Regulatory Science at VCLS, Michael (Mike) is responsible for providing both regulatory strategy and CMC consulting services…
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