Risk-Based Approaches to Building Quality into the Design & Conduct of Clinical Investigations скачать в хорошем качестве

Risk-Based Approaches to Building Quality into the Design & Conduct of Clinical Investigations

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)