Abstract
Even 20 years after the issuing of the ICH GCP Guidelines (ICH E6), the principles of GCP are still sound, and little can be criticized about them. The updates of the Guidelines and especially its Addendum [ICH E6(R2)] that in Europe became effective in 2017 have not fundamentally changed the content of this Guideline but introduced technology and approaches that were unknown when the GCP Guideline got issued for the first time. Twenty years ago clinical development was largely a paper-based process, and the Internet and even more so the Cloud were technology and tools only known to a few techies.
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Deming EW (1966) Some theory of sampling. Dover Publications, Mineola NY, USA
Imai M (1986) Kaizen: the key to Japanese competitive success. McGraw Hill, New York, USA
Lunau S et al (2006) Six sigma + lean toolset. Springer Verlag, Heidelberg, Germany
Spear SJ (2009) The high velocity edge. McGraw Hill, New York, USA
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Widler, B. (2018). Clinical Quality Management System. In: Hock, F., Gralinski, M. (eds) Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Springer, Cham. https://doi.org/10.1007/978-3-319-56637-5_42-1
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DOI: https://doi.org/10.1007/978-3-319-56637-5_42-1
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Publisher Name: Springer, Cham
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Online ISBN: 978-3-319-56637-5
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