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This symposium will highlight current and emerging topics of interest to the industry related to good clinical practice, bioequivalence and good pharmacovigilance practice.

The event will bring together regulators, investigators, clinical researchers, clinical trial staff, sponsors, research organizations, service providers, pharmaceutical and biotechnology companies, academics and patient advocacy groups.

ICH E6(R3) implementation and quality focus: Explore the shift from compliance-driven to quality-focused clinical trial conduct, featuring Quality by Design principles and risk-proportionate approaches to enhance trial efficiency and participant protection.

Innovative trial design: Learn about regulatory expectations for risk-based quality management, decentralized and pragmatic trial designs, and integration of real-world data sources from FDA, MHRA, and Health Canada experts.

Bioequivalence case studies: Gain insights from regulatory experts on strengthening application quality through critical thinking, proactive risk management and enhanced data integrity practices based on inspection outcomes and lessons learned.

Pharmacovigilance compliance updates: Hear regulatory updates on best practices, guidance and international collaborative efforts to streamline inspection processes and harmonize global expectations.

Participants will learn:

• Strategies for implementing quality by design to support proactive trial management and cultivate a quality culture that values critical thinking and transparency
• Key updates and practical application of ICH E6(R3)
• Approaches for balancing quality expectations with operational efficiency
• Regulatory expectations for incorporating decentralized and pragmatic elements into clinical trials
• Strategies to ensure participant safety and data reliability enabling reliable decision-making throughout the clinical trial lifecycle
• Clinical and bioanalytical challenges in bioequivalence studies
• Updates on regulatory collaborations, inspections and remote assessment practices
• Updates on regulation, guidance, policies and initiatives from each agency
• Pharmacovigilance inspection metrics, common inspection findings and harmonization efforts