Emmie Heeren

Kite Pharma
Senior Manager Engineering
Emmie Heeren is Head of Engineering for Kite Pharma. She has 20 years of experience in the pharmaceutical industry and has always been interested in optimizing operations from a holistic and governance perspective. Her wide range of international experiences include industrial process engineering, leading consultancy teams in automation and validation, and legal experience at competent authorities focusing on gene therapy. She is Chair of the ISPE Pharma 4.0™ Process Maps & Critical Thinking Subcommittee. She joined ISPE in 2020.

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Figure 1: Process-centric vs. data-centric approach.
Technical
Methodology to Define a Pharma 4.0™ Roadmap

In the context of data integrity, data flows are essential. The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. The key to data integrity compliance is a well-functioning data governance system1

  • 1International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised...