Translating QbD Principles to Risk-Proportionate Oversight Including RBM: Successes and Challenges

This session focuses on identifying successes and challenges with implementing a risk-based approach to sponsor oversight of clinical trials, including trial monitoring and other trial-related activities performed by contracted service providers. Panelists discuss the adoption of RBM to optimize site performance through risk management while exploring artificial intelligence’s (AI’s) potential in advancing quality management.
Speakers/Panelists:
• Nicole Stansbury, Premier Research (Association of Clinical Research Organizations)
• Patrick Nadolny, Sanofi
• Michael Walega, Bristol Myers Squibb (PHUSE)
• Kristin Stallcup, Takeda
• Steve Young, CluePoints