Thought Leader:
Taren Grom, Editor, PharmaVOICE (Moderator) Amy Kissam-Sands, Senior Vice President, Clinical Operations, Parexel Tim Audin, Senior Director, Risk Management (IRMCert) Parexel

Risk Based Quality Management (RBQM) will be the operational foundation of next generation clinical research. RBQM mandates new ways of thinking and operating that will change the clinical development process, from the concept and design of clinical trials to the infrastructure and methodologies used to conduct them. ICH E8 (R1) will guide revisions and alignments for the suite of ICH efficacy guidelines, including Revision 3 of ICH E6 (R2). The E8 (R1) blueprint delineates three overarching principles:

• Protection of clinical study participants
• Scientific approach to trial design, conduct, and analysis, including:
• Quality by Design (QBD)
• Identification and review of Critical to Quality (CTQ) factors
• Patient input into study design