This symposium will highlight current and emerging topics of interest to the industry relating to Good Clinical Practice (GCP), Bioequivalence (BE), and Good Pharmacovigilance Practice (GVP).

Presentations and panel discussions will examine the implementation of ICH E6(R3) and the cultural shift from compliance-driven to quality-focused clinical trial conduct. The sessions will highlight evolving regulatory expectations, emphasizing Quality by Design and risk-proportionate approaches to optimize trial efficiency, protect participants, and ensure reliable results. Regulatory expectations and practical strategies for risk-based quality management, innovative trial designs, including decentralized and pragmatic elements, and the use of real-world data sources will be discussed. Regulatory experts from the FDA, MHRA, and Health Canada will also provide GCP-related regulatory updates and updates on guidance, inspections, and international harmonization.

This event will include sessions where regulators share insights and lessons learned from bioequivalence case studies. It will focus on strengthening application quality through critical thinking, proactive risk management, and enhanced data integrity practices. By reflecting on inspection outcomes and key learnings from past challenges, participants will gain insights to strengthen study oversight, maintain data integrity, and enhance the overall quality of bioequivalence submissions.

Regulators will also discuss common insights/findings on key pharmacovigilance compliance topics. The audience will have the opportunity to hear first-hand updates on regulatory changes and guidance on best practices for pharmacovigilance, as well as ongoing collaborative efforts among international regulatory agencies to find efficiencies in inspection conducts and harmonize expectations.