Julien Douillet

Julien is CMC Regulatory Strategy Lead, Mundipharma, UK.

  • 2D4A6517

    TOPRA Annual lecture


    Dr Miguel Forte started his lecture by describing the fantastic cell and gene therapies (C&GT) opportunity for patients and other stakeholders in the pharmaceutical industry; he described a complex business with significant investment and value to patient in oncology and rare disease.

  • AdobeStock_244609855

    A regulatory view on the change management process for medicinal products


    An effective change control process is a critical part of good manufacturing practice (GMP), during the post-approval phase of a medicinal product’s lifecycle. This article reviews key aspects of the current EU and International Conference on Harmonisation (ICH) quality guidelines. The operational aspects of the change control process are explored and guidance is provided on how the strategic review of changes can avoid or minimise the regulatory impact.