Statistical Strategies for Quality by Design under ICH E6(R3)
Quality by Design (QbD) is a systematic approach to product development, particularly in pharmaceuticals and clinical trials, aimed at ensuring that quality is built into the design, conduct and monitoring of a study from the outset. The ICH E6(R3) Good Clinical Practice (GCP) guideline introduces a framework that promotes flexibility in study conduct, modernisation of trial approaches, and greater efficiency in clinical trial execution. Statistical elements are central to achieving these objectives.
Category: Industry Topics
How To Build a Personal Brand in Data Science Without Feeling Self-Promotional
The demand for data scientists has increased by 56% in recent years, with global data volumes set to reach 175 zettabytes this year. This has created a ‘perfect storm’ of sorts for those entering the field, but standing out in the late 2020s is becoming increasingly difficult.
Category: Industry Topics
What’s the Hype About? PHUSE’s Record-Breaking Webinars Explore Estimands and Target Trial Emulation for RWE
Discover the content of two record-breaking webinars, hosted by the Real World Data Working Group, which provided practical insights into how estimands and target trial emulation frameworks are reshaping the design and interpretation of real-world evidence (RWE) studies.
Category: Working Groups News
Welcome to Hamburg! The Host City of the EU Connect 2025
This November, PHUSE is heading to Hamburg – Germany’s dynamic port city, where history meets innovation. Known for its harbour charm, architecture and rich cultural life, Hamburg offers the perfect location for the EU Connect 2025.
Category: Events Across the Globe
