Track 8: R&D Quality and Compliance
This track is composed of a plethora of 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 23 | Short Courses
- Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
- Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management Workshop
- R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle
Monday, June 24
- Quality Management Post-Quality Management System Implementation in the Wake of ICH E6 (R2)
- Examining Essential Elements of Vendor Governance and Comparing Perspectives of Large and Emerging Biopharma
- Compliance: The Importance of Periodic Screenings to Ensure Good Inspection Health
Tuesday, June 25
- Pharmacovigilance Reporting and Quality
- Translating Academic Research into Product Development: Integrating GXPs into the Process (Part 1 of 4)
- Improving Clinical Trial Risk Management: How to Leverage the IRB's Designed Purpose
- Electronic Systems: Are Yours Fit for Purpose?
- Translating Academic Research Into Product Development: The What and Why of cGMP in Translational Science (Part 2 of 4)
- Real World Evidence: How Does its Use Challenge Quality and Compliance Programs?
Wednesday, June 26
- Improving Trial Quality by Better Preparing Site Teams
- Translating Academic Research into Product Development: The Importance of Understanding GLPs at an Early Stage (Part 3 of 4)
- Expanding Use of Interactive Response Technologies in Clinical Trials: Maintaining Data Quality and Reliability
- Global Perspective on ICH E8(R1): General Considerations for Clinical Trials
- Leveraging Data Analytics to Drive Compliance and Quality in a Risk-Based Monitoring Environment
- Translating Academic Research into Product Development: Integrating GCP Training into the Process (Part 4 of 4)
Thursday, June 27
- Case Studies from FDA and MHRA: Good Clinical Practices
Take a look at and hear from our top 10 attended sessions from DIA 2018. Download the recordings here.
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.