Objectives
- Identify the key similarities and differences between ICH E6(R2) and ICH E6(R3) at a thematic level.
- Decode how ICH E6(R3)’s high-level themes apply to clinical research practices and organizational processes.
- Apply a practical framework to evaluate compliance and prioritize actions for bridging procedural and process gaps.
Speaker(s) Bio
Leslie Sam, BA, CSSB, CQIA
Leslie Sam, President of Leslie Sam and Associates, LLC, brings over 25 years of expertise in clinical trial research, quality management, and leadership roles. As a Six Sigma Black Belt, she drives transformative solutions in the design and implementation of clinical quality management systems (CQMS), with a strong focus on building a culture of quality at every level. Leslie’s strategic approaches incorporate regulatory guidance and industry-leading practices, enabling organizations to implement risk-based quality management (RBQM) and other forward-thinking practices in clinical trial execution. Recognized for her expertise, she was sought by TransCelerate Biopharma to co-develop and co-author the industry’s conceptual frameworks for CQMS and issue management. She also contributed as a reviewer to TransCelerate’s risk management framework, leveraging her deep knowledge to influence industry standards. Leslie is widely known for applying strategic and tactical risk-based approaches that ensure data integrity, patient safety, and compliance in clinical trials.
