All MAA articles

  • AdobeStock_296306617
    Meeting Report

    HM4: Real world evidence in regulatory decision-making

    2021-11-23T13:15:00Z

    During the first part of the session, Fred Senatore discussed applications and the challenges of real word data (RWD) and real-world evidence (RWE). He opened his talk with a definition of the two, with RWD being defined as the data collected from a variety of sources, and RWE as the analysis of the source.

  • AdobeStock_210414987 (1)
    Journal

    Key steps and considerations of the EU centralised procedure

    2019-07-01T14:19:00Z

    This continuing professional development article aims to provide some of the background and key steps and considerations when using and navigating the EU centralised procedure for a new marketing authorisation application (MAA).