Abstract
This paper provides Kevin O’Donnell’s remarks on the subject topic from the inaugural Quality Business Leadership Summit, held on 01-May-2024 at Technological University Dublin. Specifically, O’Donnell discusses good quality leadership, the current focus on PQS effectiveness, two case studies of both effective and ineffective PQS’, inclusive of many of the major revision topics of ICH Q9(R1), and the relationship between quality Leadership and PQS effectiveness.
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Recommended Citation
O'Donnell, Kevin
(2024)
"ICH Q9(R1): The Quality Leader’s Opportunity for Effective, Patient-centric Decision-making,"
Journal of Applied Pharmaceutical Regulatory Science:
Vol. 1:
Iss.
2, Article 6.
Available at:
https://arrow.tudublin.ie/japrs/vol1/iss2/6
