Track 8: R&D Quality and Compliance
This track is composed of 11 sessions and is themed, End-to-End Clinical Quality – Quality Management Systems. It provides a comprehensive view of the quality landscape across the preclinical, clinical, and pharmacovigilance domains. The track focuses on 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
Sunday, June 24 | Short Courses
- R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle
- Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
Monday, June 25
- Beyond Robotics Process Automation: NextGeneration Integrated QMS for R&D
- A Quality-by-Design Approach to Trial Design and Conduct: Case Studies from the Clinical Trials Transformation Initiative
Tuesday, June 26
- Oversight in the Era of E6 (R2)
- Executives Respond to the State of the Industry Report on Risk-Based Approaches in Clinical Trials: Opportunity or Threat?
- The Risk Assessment Is Done: Now What? A Guide to Setting up a Centralized Monitoring Plan
- The Letter and Spirit of Risk-Based Monitoring: How to Creatively Implement Risk-Based Modeling and Unlock the Potential of the Team
Wednesday, June 27
- Harnessing the Power of Data and Analytics to Enhance Quality
- Determining Data Integrity: Decoding the Impact of Inspectional Observations
- Virtual Audits: Do They Achieve the Objective?
- Think Like a Regulator: Evaluating Trial Integrity
Thursday, June 28
- Assessing Your Clinical Quality Management System: An In-Depth Look at TransCelerate’s Assessment Tool
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.