Track 8: R&D Quality and Compliance
This track provides a comprehensive view of the quality landscape across the preclinical, clinical, and pharmacovigilance domains within the biopharmaceutical industry. Sessions are focused on discussing innovative and risk-proportionate approaches to managing quality that are appropriate to an evolving development paradigm and in a global context. Sessions will address key topics in GLP (Good Laboratory Practice), GCP, and PV quality, providing knowledge and resources needed to implement pragmatic, proactive, and effective quality management.
DIA recommends this track and associated sessions to professionals within biopharma, CROs, and regulatory agencies interested or working in research and development, clinical research, clinical, preclinical, or PV quality, clinical monitoring, regulatory affairs, regulatory operations, compliance, pharmacovigilance, quality control/quality assurance, and clinical quality management systems.
Included Topic Areas
ICH E series guidelines, clinical quality management systems, quality risk management, quality culture, clinical quality-by-design, proactive quality, quality indicators, risk indicators, clinical quality metrics, data quality, data integrity governance/frameworks, GCP, GLP, audits, risk-based auditing, inspection management, CAPAs (Corrective and Preventive Actions), compliance, compliance oversight, global oversight. Topics related to bioethical issues are also welcome and may be considered for a special track in the meeting.
- Quality by Design and Quality Risk Management: How to Balance Risk and Resources
- Ensuring Data Quality and Data Integrity
- Pharmacovigilance Quality: Optimizing Data Quality to Achieve PV Compliance Targets and Accurately Assess Benefit Risk Profiles
- Risk-Based Approach to Clinical Trial Oversight: Risk Management and Collaborative Transparency Between Regulators and Sponsors
- Quality Innovation: Considerations for Ensuring Clinical Trial Quality When Using Innovative Trial Designs (e.g., Decentralized Trials, Adaptive Designs, Pragmatic Trials)
- Maintaining GCP and Data Quality in a Changing Clinical Trial Landscape that is Implementing More Pragmatic and Proportionate Approaches for Clinical Trials.
- Quality Culture: Empowering Quality Professionals in Enabling Innovation
- Evolving Approaches to Inspections and Associated Inspection Outcomes