What keeps drug safety leaders awake at night?

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We have been busily finalising the drug safety agenda for 2012's event which is proving very exciting with all the changes the industry (Europe especially) is facing. It made me take some time to review some of the interesting topics raised at the 2011 World Drug Safety Congress Europe. Roche's Philippe Van der Auwera gave an outstanding (as always) big picture presentation on the challenge in the industry. Some of the points he raised gave a great perspective on how senior drug safety leaders see the challenges of the industry.


He used information from a McKinsey Safety Leader survey that asked what keeps you awake at night. Some of the broad industry safety issues raised included:


  • Create strong safety/PhV governance working effectively across functions
  • Capitalise on current safety/PhV awareness to attract and develop top talent
  • Manage and develop REMS proactively
  • Outline strategy for risk communications to public and external stakeholder
  • Build organisational foundations for early signal detection
  • Develop and employ novel data evaluation methods
  • Define role of PhV in integrated risk/benefit assessment
  • Manufacturing Quality Systems
  • Asia Pacific & other emerging markets


Another topic was focussed on safety risk management. Philippe highlighted six core challenges of safety risk management. These were:

  • Data challenge
  • Communication challenge
  • Organizational challenges
  • Talent challenge
  • Money challenge
  • Strategic challenge


Do you agree with these points or what do you see as the biggest challenges

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