This message is sent to you by FDA Newswatch Risk-Based Quality Management SummitJune 3-4, 2021 Online Live Streaming Sponsored by DGEvents |
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! Top Reasons to Attend
AGENDA
June 3, 2021
9:00-9:15 AM
Chairperson’s Opening Remarks
KEYNOTE
9:15 – 10:00 AM
Reach For World Class Enterprise Risk Evaluation and Adaptive Integrated Monitoring
You may need to completely disrupt your operating model, process, people and technology in order to arrive at world class risk management. Embrace a strategy that builds and strengthens core competencies to achieve next level performance.
Speaker:
DEVELOP, IMPLEMENT AND MAINTAIN AN RBQM MASTER PLAN
10:00 – 10:45 AM
Secrets to Success for an End-to-End Comprehensive RBQM plan
The key factor for successful RBQM implementation and ongoing management hinge upon setting up for success at the onset. In order to maximize the value of your RBQM plan you must be intentional with how the components fit together. Quality will suffer if a strategic, end-to-end approach is overlooked.
Speaker:
11:00– 11:45 AM
PANEL: Maintain the Momentum of Proactive Risk Management
The COVID 19 pandemic has forced industry to “walk the walk” when it comes to quality risk management. As we begin to move out of COVID, there is an opportunity to apply the lessons learned to maintain a level of risk tolerance and to be more agile in clinical trial oversight.
Speakers:
KEYS TO SUCCESSFUL QUALITY BY DESIGN (QBD)
11:45- 12:30 PM
Continually Improve and Innovate in a “Culture of Quality”
Dr. Joseph M. Juran developed the concept of quality by design (QBD) and many industries have embraced it. What does it mean for the biopharmaceutical and device industries? How far we have come and where we will be in the near future?
Speaker:
12:30 – 1:00 PM
Lunch
1:00 – 1:45 PM
Focus on a Systematic Approach to Risk Management Including Process Controls
There is a tremendous opportunity to leverage the relationship between clinical and manufacturing functions to advance quality and risk management systematically. Biopharma manufacturing has leveraged process controls to ensure continuous quality improvement and quality by design over the last number of years.
Speaker:
1:45– 2:30 PM
Avoid Setting Unreasonable Quality Tolerance Limits
There is a strong correlation between placing reasonable thresholds and setting effective key risk indicators. Consider whether it’s practical and timely to move away from attempting perfection to a space where you define quality and have acceptable errors inside.
Speaker:
2:30 – 3:15 PM
Ensure Scalability of Your Risk Based Quality Management Systems
Building or buying new technology tools is not the most difficult aspect of implementing a successful RBQM system. Scalability of the usage of the tool is the hardest piece and it is critical to lay the foundation correctly to ensure success of the system.
Speaker:
Day 1 Concludes
June 4, 2021
9:00-9:15 AM
Chairperson’s Review of Day One
EVALUATE RISK IN MONITORING TYPES
9:15 – 10:00 AM
PANEL: Evaluate Shifts in Data Monitoring Pre and Post COVID-19
Sponsors had been somewhat slow to adapt to technology-based approaches to monitoring trial data. In the wake of COVID, the absence of on-site monitoring has led to an acceleration in the adoption of these technologies.
Speakers:
10:00 – 10:45AM
Reduce Source Data Verification and Appraise the Site Monitoring Role in Risk Based Monitoring
Closing the loop on risk based monitoring and ensuring that we evolve the site monitor’s role to tie together the risk assessment and the central monitoring findings is a critical component to a successful RBQM program.
Speaker:
ADAPT AND IMPLEMENT ROBUST RISK BASED QUALITY MANAGEMENT
11:00-11:45PM
Analyze Expedited Development and Use of a New Data Visualization Dashboard to Address the Impact of Covid-19 on our Clinical Trials
With the Covid-19 pandemic upon us, we had to create a quick and easy way to review data trends at multiple levels for our clinical trials.
Speaker:
11:45– 12:30PM
Gather Lessons Learned About RBQM from Vaccine Trials
Discover more about the management of RBQM in vaccine trials and key takeaways.
Examine frequency analysis
Speaker:
12:30- 1:00PM
Lunch
1:00- 1:45 PM
Prepare for FDA Inspection and Exact a Risk Based Audit Strategy
Learning from examples of 483 warning letters is a good way to know what to look out for and stay “inspection ready”. Establish and maintain a single source of truth for study and site quality management, to ensure inspection readiness.
Speaker:
1:45- 2:30PM
Foster An Audit and Oversight Strategy for Vendor Quality Management
Vendor oversight is a critical piece of the risk based quality management plan (RBQM). The sponsor is responsible for the quality performance of CROs, vendors and subcontractors.
2:30-2:45PM
Chairperson’s Closing Remarks
Day 2 Concludes
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