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 event to specialize on this topic – streaming your way on a proven interactive online platform!
- 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”
- 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
Who Should Attend:
- Study Monitoring
- Clinical Operations
- Study Monitoring/Management
- Data Management
- Medical Writing
- Clinical Research
- Quality Assurance
- Clinical Outsourcing
- Regulatory Affairs