Risk-Based Approaches to Building Quality into the Design and Conduct of Clinical Investigations - Regulatory Perspectives of QbD and RBM
This session spotlights quality management principles in the design and conduct of clinical investigations with a focus on integrating QbD and RBM approaches based on recent FDA guidances. Panelists discuss how regulators and clinical trial sponsors are approaching these principles.
Speakers/Panelists:
• M. Khair ElZarrad, US Food and Drug Administration
• Fergus Sweeney, Clinical Trial Expert, Retired
• David Nickerson, EMD Serono (Pharmaceutical Research and Manufacturers of America)
• Kerstin Koenig, GSK plc (European Federation of Pharmaceutical Industries and Associations)