Optimising human factors within regulatory processes to accelerate safe biopharmaceutical innovation

• At: Glasgow (Scotland) (2018)
• Type: Poster
• Poster code: POS-RSC-005
• 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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