Part 1: Risk-based Quality Management (RBQM) Video Series
RBQM calls for new ways of operating that will change the clinical development process. ICH E8 (R1) will guide revisions and alignments for the suite of ICH efficacy guidelines. Parexel’s RBQM experts Amy Kissam-Sands and Tim Audin, Senior Director, Global Biometrics Group Lead sat down with Taren Grom, Editor, PharmaVOICE to discuss the ICH E8 (R1) guidance, its impact on the industry and how we can fill the gaps.
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