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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 LeadsEmail
Nathalie van Borrendam, Johnson & Johnsonnvanborr@its.jnj.com
Annett Keller, Boehringer Ingelheim annett.keller@boehringer-ingelheim.com
Alex Pearce, PHUSE Project Assistant 

alexandra@phuse.global


 
  • Presented paper outcomes at Phuse US Connect Feb 2024 
    • Presented paper outcomes to the Phuse-FDA meeting in March 2024

    Status
    colourBlue
    titleCurrent Status
    Q2 2024

    Q3 2024

    • Storyline for the second White Paper have been agreed
    • Working on Developing the White Paper



    Objectives & DeliverablesTimelines
    Challenges in QTL threshold setting – Experience sharing and high-level recommendations for the industryQ3 2022

    Guidance document on QTL threshold-setting methodologies

    		Q1 2023