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Orphan Drug Regulation in Europe – Fall 2002

Post thumbnail Orphan Drug Regulation in Europe – Fall 2002

The European Member States have decided that they cannot accept that certain individuals be denied the benefits of medical progress because these individuals suffer from a disease that affects only a small fraction of the population. It is, therefore, their role to facilitate access to medicinal products for these patients, provided that these products are as safe and effective as any other medicinal product, and meet the same quality standards.

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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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