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Session 6, Track A: Clinical Trials Operations and Management – Designing Quality into Innovative Clinical Trials
Session Chair(s)
Monica Lizano, MD, MBA
Global Director, Clinical Quality Management
Merck Chile, Chile
Clinical trials are evolving to better meet participant expectations by enhancing data collection methods, incorporating decentralized and pragmatic elements. The ICH E6(R3) Good Clinical Practice guidelines have adapted to reflect these advancements, highlighting the importance of quality by design (QbD), integrating quality management guidance, and actively promoting engaging key stakeholders to implement quality by design in protocol development.
Early identification of Critical to Quality (CtQ) factors during protocol design, along with understanding the associated risks and their mitigations, plays a vital role in shaping the protocol and the operational and quality plans that direct trial conduct. This proportionate, risk-based approach ultimately leads to clinical trials that are fit for purpose—ensuring that all important trial components effectively address the research question, support the generation of reliable results, and prioritize participant safety. This presentation will delve into how publicly available tools can aid companies in navigating the implementation of ICH E6(R3), providing examples that illustrate these concepts.
Learning Objective : At the conclusion of this session, participants should be able to:- Recognize changes in regulations to address the evolution in clinical trial design
- Identify innovative clinical trial design and the challenges in their implementation
- Define the quality by design concept and the quality risk management process
Speaker(s)
Designing Quality into Clinical Trials
Monica Lizano, MD, MBA
Merck Chile, Chile
Global Director, Clinical Quality Management
Clinical Trial Operations and Management: Quality Design for Innovative Clinical Trials
Cristina Elena Papayannis, DrMed
ANMAT Ministry of Health, Argentina
Medical Doctor
Patient Perspective
Florencia Braga Menendez
ALAPA Alianza Argentina de Pacientes, Argentina
Directora de Proyectos
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