DAY TWO | FRIDAY, APRIL 24
8:30 REGISTRATION & WELCOME COFFEE
8:55 CHAIRPERSON’S OPENING REMARKS
9:00 ASSESSING LEVELS OF CLINICAL RISK AND THE DEVELOPMENT OF APPROPRIATE RESPONSES
Aspects of a clinical study such as safety, patient population and documentation all present complications that can arise with varying levels of significance. In a robust risk mitigation plan, the levels of these risks and the associated responses have been incorporated into a study’s clinical protocol. When building such contingencies, many clinical quality teams have struggled to determine what level of rigor should be implemented for a given risk. For a synopsis on building appropriate responses into risk monitoring tables, different risk scenarios will be presented to demonstrate how these events are assessed and accounted for in risk mitigation plans.
- Overview of risk factors to be included in protocols
- Assessing level of severity for various risk factors
- Building appropriate responses based on severity
Phillip Doyle, Executive Director, Quality Assurance, EXELIXIS
9:45 DISCUSSING INTERPRETATIONS OF ICH GUIDELINES ON RISK MITIGATION PROCESSES
As the influence of ICH continues to expand globally, clinical quality assurance professionals are paying close attention as to how the organization’s guidelines are being interpreted and implemented. The ICH E6 second revision regarding the organization’s perspective on good clinical practice was intended to drive quality by design and has allowed for the justification of a greater emphasis on risk based monitoring throughout clinical trials. Questions surrounding whether this improves the clinical trial process remain and clinical quality teams have struggled to determine how these guidelines can be best implemented.
Charlene Atkinson, Director Clinical Quality Assurance, AMICUS THERAPEUTICS
10:30 COFFEE AND NETWORKING BREAK
11:00 FIRESIDE CHAT: FDA AUDIT EXPECTATIONS AND BIORESEARCH MONITORING TEAM COMMON CITATIONS
As included in the FDA’s top initiatives for 2020, risk monitoring and data integrity are of particular importance to quality assurance professionals looking to update clinical processes with the incorporation of strategic risk based monitoring. As the FDA’s field personnel responsible for the assessment of data integrity and site audits, the findings and citations of Bioresearch Monitoring Teams play a significant role in how quality teams work to implement these processes. Following a presentation on the FDA’s most common citations and enforcement actions, attendees will have an opportunity to ask questions and receive clarity on compliant processes that can help avoid regulatory issues during a drug’s development.
Klaus Goodwin, Sr. Director, Head GCP/GLP Quality Assurance, RADIUS HEALTH, INC.
11:45 LUNCHEON FOR SPEAKERS, SPONSORS AND ATTENDEES
1:00 STRATEGIES FOR ENSURING QUALITY CONTINUITY WHEN OUTSOURCING CLINICAL OPERATIONS
For many pharmaceutical manufacturers, clinical research organizations (CROs) provide the best option for controlling costs and upholding quality standards throughout the research and development phase of a new drug. While CROs can offer and expansive set of otherwise unavailable resources, the sponsor’s internal quality team must take responsibility for ensuring trials are conducted in compliance and according to established clinical protocol. By understanding the most common citations found through CRO QA, clinical quality professionals will gain insight on how to build CRO risk mitigation into overall clinical plans and maintain thorough oversight of external clinical operations.
- Clinical operations establishment of on-site quality standards
- Building communication protocol in the event of deviations
- Ensuring clinical quality through CROs with limited resources
Sara Smith, Global Lead, Global Clinical Quality, OTSUKA
1:45 CRO CONSOLIDATION & TURNOVER: IMPACT ON CLINICAL RISK MANAGEMENT PLANS
Sponsors rely on clinical research organizations to carry out clinical studies, but the consolidation of these organizations, coupled with employee retention challenges, has often introduced untenable risk into a study after the clinical trial is already underway. Retraining CRO staff has become a costly and time consuming factor for quality assurance teams building clinical models with the priority of risk mitigation. For a look at the least restrictive methods of retraining CRO staff, this session will address examples of clinical staff retraining is being built into risk scenarios in clinical protocols.
- Overview of previous and expected CRO consolidations
- Cost of retraining staff and benefits of risk mitigation
- Building CRO turnover expectations into risk monitoring
Barbara Tantillo, Associate Director Quality Assurance R&D, DAIICHI SANKYO, INC.
2:30 COFFEE AND NETWORKING BREAK
3:00 REMEDIATING DOCUMENTATION PROCESSES TO FULFILL FDA DATA INTEGRITY EXPECTATIONS
As part of the FDA’s top initiatives for the year 2020, clinical data management and integrity have become a renewed focus for clinical quality professionals. The adoption of new data collection technologies and evolving regulatory standards have forced many clinical quality teams to remediate documentation processes and realign protocol for managing diversions, risk monitoring, and demonstrating clinical oversight. Following an example of how some pharmaceutical companies have fallen behind on documentation compliance, clinical quality teams will benefit from hearing remediation strategies for correcting data collection systems.
- Overview of FDA’s data integrity initiatives and expectations
- Benchmarking compliance in documentation of clinical data
- Available remediation resources for documentation protocol
Marc Cromer, Director, Computer Systems Lifecycle Management, AVANIR
3:45 DEVELOPMENT OF ROOT-CAUSE CORRECTIVE AND PREVENTATIVE ACTIONS
As risk based monitoring becomes a stronger focus in the development of pharmaceuticals, retroactive quality controls like corrective and preventative actions (CAPAs) still weigh heavily on the success of a clinical trial. Intended to address the root cause of clinical deviations, some CAPAs have become over reliant on “fix-alls” like retraining as a way of documenting that deviations are being managed. For insight into the important role of CAPAs while prioritizing quality by design, a clinical quality assurance expert will demonstrate methods for developing these controls that will address the root cause of protocol deviations.
Michael Torok, Clinical Quality Assurance Head, ASTELLAS PHARMA
4:30 END OF CONFERENCE