戻る Agenda
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)
Embedding Quality by Design- A Mindset Shift for Modern Clinical Trials
Arati Borkar
DiagnoSearch Life Sciences, India
Director - Quality Assurance
From Compliance to Culture – Reimagining Quality as a Strategic Driver in Clinical Trials
Shehnaz Kairas Vakharia, MSc
ADAMAS Clinical Quality Consulting Pvt Ltd, India
Vice President
Embracing ICH E6 (R3) Principles, Harnessing Risk-Based Quality Management (RBQM) and AI for Proactive Decision-Making
Artem Andrianov, PhD, MBA
Cyntegrity Germany GmbH, Germany
CEO & Founder
With Additional Participation Of:
Nithya Gogtay
SGS Medical College & KEM Hospital, India
Professor and Head, Department of Clinical Pharmacology
With Additional Participation Of:
Divakar Kolli
Cipla, India
Director- Development Quality Assurance