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CT.S2. – Quality Management in Clinical Trials- Embedding ICHE6(R3) Principles
Session Chair(s)
Sanish Davis
R&D Director, GCO India, Johnson & Johnson Innovative Medicine, India
This session delves into the evolving landscape of quality management in clinical trials, anchored in the principles of ICH E6(R3). Speakers will discuss the shift from compliance-driven approaches to a culture of proactive quality, emphasizing Quality by Design, Risk-Based Quality Management, and the role of AI. The panel will explore how to strategically embed quality across trial planning and execution—balancing innovation, regulatory oversight, and patient trust to elevate outcomes in today’s complex research environment.
Speaker(s)
Arati Borkar
Director - Quality Assurance, DiagnoSearch Life Sciences, India
Embedding Quality by Design- A Mindset Shift for Modern Clinical Trials
Shehnaz Kairas Vakharia, MSC
Vice President, ADAMAS Clinical Quality Consulting Pvt Ltd, India
From Compliance to Culture – Reimagining Quality as a Strategic Driver in Clinical Trials
Artem Andrianov, PHD, MBA
CEO & Founder, Cyntegrity Germany GmbH, Germany
Embracing ICH E6 (R3) Principles, Harnessing Risk-Based Quality Management (RBQM) and AI for Proactive Decision-Making
Nithya Gogtay
Professor and Head, Department of Clinical Pharmacology, SGS Medical College & KEM Hospital, India
With Additional Participation Of:
Divakar Kolli
Director- Development Quality Assurance, Cipla, India
With Additional Participation Of: