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Realizing Transformational Technologies in Regulated Pharma World

David Brooks
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Information Systems Track at the 2018 ISPE Annual Meeting & Expo

Fantastic, isn’t it! Information technologies are evolving at such a pace that it seems there is something new to be excited about almost every week. This week’s headlines: MIT has announced artificial intelligence software that can see people through walls, virtual reality is being used for health and safety training, and a study claiming a chatbot has better diagnosis accuracy that human physician.

In our sector, just as with the chatbot diagnosis system, it is clear these new technologies also create new risks and new challenges. Like self-driving cars, which are forcing us to reconsider fundamental questions of accountability and safety decision making – we need to understand the risks and adapt our strategies for using and controlling these technologies around those risks.

GAMP5® is ten years old - older than many of the technologies that are finding their way into the regulated life sciences sector, and definitely older than our understanding of many of the risks we now have to deal with.

So – is it still relevant?

My answer is a resounding Yes! GAMP5® was written to be a flexible and adaptable framework for ensuring compliance of all types of computerized system, with risk management at its heart.

This year, the 2018 ISPE Annual Meeting & Expo track on Information Systems will focus on new technologies and new risks. We will build on the themes of previous years and explore the opportunities new technologies are offering and how the principles of GAMP guidance can be applied.

Our theme for the Information Systems track is “Realizing Transformational Technologies in Our Regulated World” and we are very excited to have sessions covering the following topics:

  • Data Integrity Strategy and Implementation – this will be an interactive workshop examining the practical implementation of the new GAMP RDI guide
  • Next Generation Manufacturing Control
  • Cybersecurity in Life Sciences
  • Cloud Computing in a Regulated Environment
  • Lessons from Global Data Integrity Case Studies
  • Transformative DATA: Aggregation & Analytics with Integrity
  • eClinical: Clinical Trial Data & GAMP Compliance

I look forward to meeting you in Philadelphia this November at the 2018 ISPE Annual Meeting & Expo – come and join us as we explore what the future holds.

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