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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: 

  • Share this acquired knowledge and common understanding within the industry. 

  • Continue the discussion on further refining the (statistical) methodology regarding threshold derivation for QTL monitoring. 

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

Email

Annett Keller, Boehringer Ingelheim 

annett.keller@boehringer-ingelheim.com

Nathalie van Borrendam, Johnson & Johnson

nvanborr@its.jnj.com

Annett Keller, Boehringer Ingelheim annett.keller@boehringer-ingelheim.com

Alex Pearce, PHUSE Project Assistant 

alexandra@phuse.global

Status
colourBlue
titleCurrent Status
Q3 2024

  • Storyline for the second White Paper have been agreed
    • Working on Developing the White Paper
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    Click above for the latest project status.

    Objectives & Deliverables

    Timelines

    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