European Medical Writers Association - Webinar Series
- heathermason
- Jul 9, 2021
- 1 min read
Another upcoming webinar hosted by the
Thursday 22nd July 2021, 14:00 CET
The role of Quality Tolerance Limits (QTLs) in clinical development, by Andy Lawton
QTLs were introduced into ICH GCP (E6 R2) in 2016 and yet their full impact can now only be realised with the introduction of ICH E8 R1 with Quality by Design (QbD).
This presentation will examine the history of tolerance limits, the role of QTLs in QbD and in clinical trials, including what and how to report them in the CSR and submissions.
Register online:
@https://emwa.org/training/emwa-webinars-programme-2021
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