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Regulatory & Access Resources

Browse our regulatory & access resources to find the latest articles, blogs, brochures, and videos from our experts. See the latest content below.

Risk-based Quality Management (RBQM) Video Series, Part One

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, Senior Vice President, Clinical Operations and Tim Audin, Senior Director, Risk Management 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.