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Human Microbiomes in Health and Disease: Strategic Options for Regulatory Science and Healthcare Policy

Post thumbnail Human Microbiomes in Health and Disease: Strategic Options for Regulatory Science and Healthcare Policy

This article describes the human microbiota and microbiomes’ strategic role in personalizing health and disease management, which is rapidly demanding diligent regulatory science and policy action to ascertain confidence and trust among consumers, patients, and healthcare providers. The authors discuss why establishing harmonized processes and standards to better understand the baseline healthy microbiota is essential to the development of strategies for nutrition and clinical applicability. They conclude that, given the complexity of issues, a well-orchestrated, multistakeholder approach is advisable for the best chance of success.

Citation Ruthsatz M, Voisin E, Lima N, D’Hondt K. Human microbiomes in health and disease: Strategic options for regulatory science and healthcare policy. Regulatory Focus. July 2020. Regulatory Affairs Professionals Society.

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    publication by

    Emmanuelle M. Voisin, PhD
    Emmanuelle M. Voisin, PhD
    Founder and CEO
    Dr. Emmanuelle Voisin founded Voisin Consulting Life Sciences (VCLS) in 1997. The firm has become a leading advisor to Biotech,…
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    Manfred Ruthsatz thumbnail
    Manfred Ruthsatz
    Executive Director at Nutrition+HealthCARE
    Manfred Ruthsatz, PhD, RAC, FRAPS, is the executive director of Nutrition+HealthCARE, Connecting Advocacy, Regulatory, and Empathy. His healthcare regulatory experience, rounded out by quality, safety, vigilance, health economics, and reimbursement, spans more than 30 years in diverse healthcare industry settings, FDA CDER’s Division of Antiviral Drug Products, and NIH’s National Cancer Institute, working on human papilloma viruses.
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    Nelson Lima
    Professor and researcher at the Centre of Biological Engineering of University of Minho and executive director of MycoTec Lda.
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    Kathleen D’Hondt
    Molecular Cell Biologist