Project |
Scope |
The Project has successfully completed the first step of clarifying the |
definitions and labels |
linked to QTL monitoring. Recommendations on how to derive thresholds for QTL monitoring have been developed. The next stage shall be to:
Closely follow ICH (R3) developments regarding risk-based monitoring and discuss/evaluate whether this has impacts on the guidance provided so far (QTL vs. acceptable range). |
Project Leads | |
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Nathalie van Borrendam |
, Johnson & Johnson | nvanborr@its.jnj.com |
Annett Keller |
, Boehringer |
Ingelheim | annett.keller@boehringer-ingelheim.com |
Alex Pearce, PHUSE Project |
Assistant |
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Objectives & Deliverables | Timelines |
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Challenges in QTL threshold setting – Experience sharing and high-level recommendations for the industry | Q3 2022 |
Guidance document on QTL threshold-setting methodologies | Q1 2023 |
Status | ||||
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