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Optimising human factors within regulatory processes to accelerate safe biopharmaceutical innovation

  • At: 2018 FIP Congress in Glasgow (Scotland)
  • Type: Poster
  • By: PARSONS, Andrew (Reciprocal Minds Limited)
  • Co-author(s): Andrew Parsons: Reciprocal Minds Limited, Welwyn Garden City, United Kingdom
    Allison Morgan: Metis Clinical, Ascot, United Kingdom
    Simon Whiteley: Whiteley Aerospace Safety Engineering & Management Limited, Swindon, United Kingdom
    Crystal Ruff: Illumina, Cambridge, United Kingdom
    Fiona Day: Beaconbrands , London, United Kingdom
    Julia Mironova: Beaconbrands, London, United Kingdom
    Brian Edwards: NDA Regulatory Science Ltd, Leatherhead, United Kingdom
  • Abstract:

    Background

    Human factors (HF) allow optimisation of the interface between people and all aspects of a system. Despite recent technological advances, the basic principles of medicines development have not changed since the ’80 and have been stated to be “broken” [1].

    Methods

    Using a system engineering model (STAMP) [2] the BP development process was

    ..

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Last update 13 May 2019

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