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 23 | Short Courses
- R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle
- Quality Tolerance Limits/Issue Management: Taming the Beast of Clinical Development Risk
Included Topic Areas in R&D Quality and Compliance
DIA 2018’s Program and full list of sessions will be available in January. Meanwhile, see what topics and priorities we are designing content for.
- How do the changing approaches to clinical research [risk-based monitoring (RBM), quality by design (QbD), technology/cloud, ePRO, eConsent, virtual trials, real world evidence, etc.] affect your QMS/Quality Management practices
- ICH E6/E8 renovation: an update on transformation of expectations
- Vendor qualification and oversight — are current practices working to ensure quality performance?
- Impact of data governance practices and data standards on data quality: using predictive analytics
- Impact of quality-by-design approach on clinical trial planning, conduct, and outcomes
- Best practices for quality risk management in clinical trials
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.