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 good laboratory practice (GLP), good clinical practices (GCP), and pharmacovigilance (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.
Priority Topics
- Quality by Design (QbD) and Quality Risk Management (QRM)
- Maintaining GCP Compliance and Data Quality when Using Modern Trial Designs and Operational Approaches, Such as Decentralized Trials, Pragmatic Trials, Master Protocol Designs, and Studies Using Real-World Data (RWD).
- Pharmacovigilance Quality: Optimizing Data Quality to Achieve PV Compliance Targets and Accurately Assess Benefit Risk Profiles- Using Advanced Analytics for Good Pharmacovigilance Practices Quality
- The Role of Good Data Governance in Promoting Clinical Trial Quality
- Risk-Based Quality Monitoring (RBQM)
- volving Approaches to GCP/PV Quality, and to Inspections and Associated Inspection Outcomes