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
Sunday, June 14 | Short Courses
- #24: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
- #33: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle
Monday, June 15
- ICH 30th Anniversary Series: The Role of Efficacy Guidelines
- Benchmarking and Identifying Opportunities to Improve Intentional Dose Non-Adherence in Clinical Trials
Tuesday, June 16
- Implementing Quality by Design for Clinical Trials: New Tools, Case Studies, and Multi-Stakeholder Discussion
- GCP Quality and Compliance: The Regulators’ Perspective
- Sponsor and Regulator Challenges, Risks and Mitigation Strategies for Ensuring Third-Party Oversight of Vendors: Is Your Study Data at Risk?
Wednesday, June 17
- Detection of Anomalies in eCOA Data and Metadata for More Preemptive, Evidence-Based Risk Management
- Electronic Informed Consent: Global Perspectives
- Impact of Advanced Data Analytics Capabilities on Quality and Compliance Activities: Overview and Case Studies
- Opportunities and Challenges for ICH E6 (GCP) Renovation
- Pharmacovigilance Inspections: Leveraging Inspections Readiness as a Driver of Quality in Your Organization
- Clinical Safety: Approaches to Assure Compliance in the Pharmacovigilance and GCP Interface
- Quality Oversight of Pharmacovigilance Processes
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.