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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


Developing the 2nd White Paper 

Status
colourBlue
titleCurrent Status
Q4 2023

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