BioQCExpert Insight & Answers | Explore how multivariate optimisation tools such as risk assessment, Design of Experiments, and MODR studies can be applied modularly to strengthen method development and inform validation, without replacing fundamental analytical understanding.
BioQCOn-Demand Presentation by Prof. Sandra Furlanetto (University of Florence) | Learn how the Analytical Target Profile functions as a forward-looking framework for defining performance criteria under ICH Q14, and understand how AQbD shifts method development from trial-and-error to a rational, knowledge-driven process applicable to both small molecules and biopharmaceuticals.
BioQCOn-Demand Presentation by Dr. Cyrille Chéry (UCB) | Discover how prior knowledge can be formally integrated into the risk assessment process to reduce redundant effort across projects, and explore how risk scoring and mitigation planning guide development decisions, including when targeted experiments are needed to validate a parameter's assigned risk level.
BioQCOn-Demand Presentation by Dr. Lars Geurink (Batavia Biosciences) | Understand what the Analytical Procedure Control Strategy is under ICH Q14, how it connects every stage of method development into a coherent control framework…Understand what the Analytical Procedure Control Strategy is under ICH Q14, how it connects every stage of method development into a coherent control framework, and why "fit for purpose" is the correct standard for evaluating analytical procedures.
BioQCOn-Demand Presentation by Dr. Christof Finkler (F. Hoffmann-La Roche AG) | Understand the objectives and development history of ICH Q14, and learn how the minimal and enhanced approaches form a spectrum of increasing procedural understanding, lifecycle flexibility, and more suitably justified established conditions.
BioQCOn-demand Presentation | Gain a comprehensive overview of ICH Q14 and understand the shifting regulatory landscape around analytical procedure development, including the balance between enhanced risk-based approaches and existing industry practices.
