Risk-Based Quality Management Summit

A risk-based approach to clinical trials can help you quickly reduce trial complexity and costs while getting the most out of your R&D budget. Selecting the best data management tool can help you conserve time and resources by refocusing your study team around higher value tasks.

The Risk-Based Quality Management Summit helps you establish cross-functional risk-management teams to oversee your clinical trials, cutting down risks and accelerating drug development. This is the only life science industry conference to specialize on this topic – streaming your way on a proven interactive online platform!

Top Reasons to Attend

Sharpen skills for risk identification and ensure assessments feed into monitoring programs
Discuss whether regulators will continue to accept remote monitoring and digital technologies post COVID-19
Understand “Culture of Quality” and baseline for using QBD by linking ICH6
Consider why QTLs and KRIS must line up and how QTL management can be more robust
Learn from examples of 483 warning letters about what to look out for and stay FDA “inspection-ready”

Agenda at a Glance

Hear from Pfizer about lessons learned on RBQM from COVID-19 vaccine trials and Janssen on the impact of COVID-19 on other trials
Benefit from an unparalleled speaking faculty of experts from Merck, Abbvie, BMS, bluebird bio, Alexion, Pfizer, Janssen, Regeneron and more!
Participate in question and answer panel on how to maintain a level of risk tolerance and become more agile in clinical trial oversight
Learn to focus metrics management on what regulators expect in QBD
Experience keynote speech from Andy Lee, SVP, Head of Global Clinical Trials Operations, Merck Research Laboratories about developing the right tools and retaining employees to reinvent monitoring for the future