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Moderators
MyRBQM Academy by Cyntegrity
Targeted education helps clinical research teams embrace the implementation process and contribute to its success, ensuring your organization's RBQM strategy has the components it needs to meet regulatory expectations.
Established in 2019, Cyntegrity's MyRBQM® Academy units first-level online education, comprehensive instructor-led training, and practical case study workshops. Learn more at www.academy.cyntegrity.com
GUEST SPEAKER:
Shehnaz Vakharia
Vice President, APAC
ADAMAS Clinical Quality Consulting Pvt Ltd
Shehnaz is a highly accomplished clinical research professional based in India. She brings nearly two decades of experience in clinical research, complemented by a long-standing background in Quality Assurance audits and assessments. Shehnaz has conducted more than 200 audits across APAC, Europe, and Africa and demonstrates strong expertise in Quality Management System (QMS) consultancy and in delivering comprehensive audit programs.
Artem Andrianov (PhD)
CEO & Founder
Cyntegrity
With over 25 years in the pharmaceutical industry, Dr. Artem Andrianov is a leading expert in RBQM and clinical data quality.
As the CEO of Cyntegrity, he specializes in data-driven risk management in clinical trials. His academic background includes a Ph.D. in Mathematical Modeling and an Executive MBA.
Appointments
- June 9, 2026, 2:00 PM - 3:00 PM
Description
Biopharma dealmaking is becoming more selective, while clinical data is increasingly generated across complex, multi-party environments.
In this setting, traditional due diligence often focuses on the data package but gives limited visibility into how that data was generated, how oversight was exercised, and what risks may still be embedded in the study.
This is where many post-deal challenges originate.
There is also renewed attention on data integrity, fraud, and misconduct risk. These are not isolated issues but part of a broader operational complexity that requires a more structured approach to detection.
In this session, Cyntegrity and ADAMAS will present a practical approach to clinical R&D due diligence that goes beyond document review.
You will learn how to:
• Assess data credibility and provenance
• Identify potential risk signals within study data
• Evaluate sponsor oversight and inspection readiness
• Understand the execution risk behind key milestones
The session will also introduce a simple checklist to help structure due diligence discussions and identify where deeper review is needed.
Who should attend
Corporate Development, BD & Licensing, Clinical Development, QA/GCP, and Due Diligence leaders responsible for evaluating or integrating clinical assets.
ABOUT "mindsON RBQM" WORKSHOPS
The mindsON RBQM workshops provide practical, system-agnostic guidance on the challenges of implementing and executing Risk-Based Quality Management (RBQM) in day-to-day clinical trial operations. These sessions emphasize interactive dialogue and problem-solving, offering a collaborative space to share experiences, explore strategies, and tackle real-world challenges.
Rooted in Quality by Design (QbD) principles, mindsON RBQM focuses on system-agnostic concepts and strategies. For those looking to see these principles applied through technology, the actON QbD series offers complementary workshops with live demonstrations of use cases powered by the MyRBQM Portal.
Whether you choose to participate or simply observe actively, mindsON RBQM provides the knowledge and tools you need to navigate RBQM implementation confidently and effectively.