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), Risk-based Quality Management (RBQM), and Risk-Based Monitoring (RBM)
- Maintaining good clinical practice (GCP) compliance and data quality in trials that use (1) RWD to support regulatory decision-making and (2) agile and fl xible operational approaches, such as trials that incorporate decentralized and pragmatic elements and adaptive clinical trial designs (e.g., master protocols)
- The role of good data governance in promoting clinical trial quality
- Regulatory Convergence
- Pharmacovigilance Quality