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Early Access Programmes / Compassionate Use Programmes: How to effectively deal with the challenges

Post thumbnail Early Access Programmes / Compassionate Use Programmes: How to effectively deal with the challenges

Early access programmes (sometimes also called compassionate use or temporary use authorisation) were set up because of the rapid advances in science and the legitimate expectations of physicians or patients for early access to unauthorised medicinal products prior to marketing authorisation and commercial launch (with the assumption that a favourable risk: benefit exists). This paper discusses the possible pathways to an early access programme.

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    whitepaper by

    Jean-Luc Béjot
    Jean-Luc Béjot, M.D., MBA
    Vice President, Corporate Strategy
    As Vice President, Corporate Strategy Jean-Luc works closely with the CEO and the Executive Committee at VCLS to drive the…
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    Emmanuel Prades
    Emmanuel Prades, M.Sc.
    Senior Director, Clinical & Vigilance Operations
    Heading the clinical trial submission and operations team, Emmanuel provides technical expertise in clinical project management and strategy as well as…
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