Designing Risk-Based QA Oversight for Clinical Trials Under ICH E6 (R3)

Biotech, Clinical Trials, Drug Discovery & Development, Life Science, Pharma, Pharmaceutical Regulation,
  • Monday, April 27, 2026 | 10am EDT (NA) / 3pm BST (UK) / 4pm CEST (EU-Central)
  • 60 min

Are your Quality Assurance (QA) processes truly fit-for-purpose under ICH E6 (R3)?

ICH E6 (R3) elevates expectations for proportionate, risk-based oversight across the clinical trial lifecycle, and places new emphasis on using risk intelligence to focus effort where it matters most.

In this webinar, ADAMAS Consulting and Cyntegrity will demonstrate how data-enabled risk intelligence can be systematically derived from clinical trial data to support risk-based, proportionate, and fit-for-purpose QA strategies. The speakers will show how the AI-augmented MyRBQM® system can be applied to identify and prioritize underlying drivers of non-compliance with the protocol, GCP, and applicable regulatory requirements, enabling QA teams to move from periodic, retrospective checks to continuous, insight-driven oversight.

The session includes a practical walk-through of how risk intelligence can be operationalized; from protocol and critical-to-quality (CtQ) considerations through to ongoing analytics that highlight emerging site- and subject-level signals, helping teams target audits and interventions proportionately and with clear rationale.

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Speakers

Shehnaz Vakharia, Vice President APAC, Executive ADAMAS Consulting

Shehnaz Vakharia, Vice President APAC, Executive ADAMAS Consulting

Shehnaz Vakharia is a leading professional in the global pharmaceutical industry with 28 years of experience in clinical research, specialising in Good Clinical Practice (GCP) Quality Management System (QMS) Consulting and Audits.

In the past two decades, she established and scaled up two GxP audit firms in India and founded and co-Directed a Diploma Course in Clinical Research in collaboration with St. Xavier’s College Mumbai, a legendary educational institution.

Apart from conducting over 200 GCP audits globally for wide range of therapeutic areas, systems and processes, Shehnaz has lead numerous process optimization projects and championed various innovative strategies, including the use of advanced analytics for quality assurance and management.

She is currently Vice President, Asia Pacific Region for ADAMAS Consulting and an active member of ISCR, RQA, SQA and DIA Organizations.

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Dr. Artem Andrianov, Managing Director, Founder, Cyntegrity Germany GmbH

Dr. Artem Andrianov, Managing Director, Founder, Cyntegrity Germany GmbH

With over 25 years in the pharmaceutical industry, Dr. Artem Andrianov is a leading expert in clinical data quality and biostatistics. As the CEO of Cyntegrity, he specializes in data-driven risk management in clinical trials. His academic background includes a PhD in Mathematical Modelling and an Executive MBA. Dr. Andrianov co-founded Cyntegrity in 2013, with a focus on advancing RBQM. His specialized knowledge spans Spirometry, ECG, Oncology, ePROs and clinical data management. Committed to making clinical trials safer and more reliable, Dr. Andrianov is a key figure in the evolution of RBQM.

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Who Should Attend?

This webinar will appeal to:

  • QA and Compliance leaders overseeing GCP audit strategy and quality governance
  • Clinical Operations leaders and Study Managers responsible for trial execution and oversight models
  • RBQM / Central Monitoring leads developing KRIs, QTLs and risk review processes
  • Clinical Data Management and Biostatistics / Data Science teams supporting analytics-driven oversight
  • CRO oversight and Vendor Management professionals managing third-party governance expectations
  • Regulatory, Inspection Readiness and QMS stakeholders

What You Will Learn

Attendees will learn to:

  • Translate ICH E6 (R3) expectations into a practical QA approach
  • Use trial data to generate risk intelligence and focus QA effort
  • Apply RBQM outputs to prioritize audits and actions
  • Strengthen inspection readiness with clearer rationale and documentation

Xtalks Partner

ADAMAS Consulting

ADAMAS Consulting is a leading global specialist consultancy providing independent Quality Assurance (QA) and Quality Management (QM) services across GCP, GVP, GLP, CSC, and GMP. With offices across three continents, we deliver expert compliance solutions to pharmaceutical, biotech, and healthcare organizations worldwide. For over 25 years, ADAMAS has conducted thousands of GxP audits in 100+ countries for 800+ international clients, ensuring the highest regulatory and quality standards. Our team of experienced professionals supports clients in maintaining compliance, integrity, and operational excellence in clinical research and pharmaceutical development.

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