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, GCP, and PV quality, providing knowledge and resources needed to implement pragmatic, proactive, and effective quality management.
Sessions in R&D Quality and Compliance
Monday, June 21-Friday, June 25 | Short Courses
- #021A: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle
- #023P: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
Monday, June 28
- Advanced Analytics, Cross-Industry Collaboration, and Data Sharing to Change the Paradigm in Clinical Quality
- Artificial Intelligence Validation Framework: Is it New and Different?
- Risk-Based Remote Site Monitoring
- Culture of Quality: A Competitive Advantage
Tuesday, June 29
- New Approaches to Inspections: Collaboration and Cooperation Across Stakeholders to Verify Quality and Compliance Through Remote, Off-Site, and Record Sharing Approaches
- GCP Quality and Compliance: The Regulator’s Perspective
- Innovative Approaches to Trial Execution, Quality, and Compliance
Wednesday, June 30
- Digital by Design: Embedding Digital Across the Enterprise and the Product Lifecycle
- Assessing Risk in the Pharmacovigilance System for the Purpose of Audit and Inspection
- Companion Diagnostics: Could Co-Development Be Expedited to Facilitate Access to Accelerated Novel Therapeutics?
Thursday, July 1
- Risk-Based Quality Management and Monitoring: Practical Approaches
- Regulator Perspective: Maintaining GCP During COVID-19 and Beyond the Pandemic
- Predictive Compliance, Risk, and Quality Management Transformation: Will your Data Hold up to a Data Integrity Inspection?
Who is This Track Designed For?
Professionals involved 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.