Fleming Events Launches “Digital Quality in Clinical Trials” Training to Address New ICH E6 (R3) GCP Expectations
Vienna, Austria, October 28, 2025 --(PR.com)-- Fleming Events, a global provider of professional training and industry knowledge programs, has announced its upcoming masterclass Digital Quality in Clinical Trials, scheduled for 22–23 April 2026 in Vienna, Austria.
The training comes at a critical time as regulators worldwide increase their focus on Good Clinical Practice (GCP) compliance, data integrity, and the validation of electronic systems under the updated ICH E6 (R3) guideline. The new framework redefines how sponsors, CROs, and investigators must ensure quality and reliability in digital and decentralized clinical trials.
“Digital transformation is changing how trials are conducted, and compliance expectations are evolving just as quickly,” said a spokesperson for Fleming Events. “This course equips professionals with the knowledge and tools needed to align digital systems, data workflows, and vendor oversight with the new ICH E6 (R3) requirements.”
The two-day training will be led by a former MHRA Group Manager and member of the ICH E6 (R3) Expert Working Group, together with a Digital Clinical Trials Innovator. Through a mix of case studies and regulatory insights from EMA, MHRA, and FDA inspections, participants will gain a clear understanding of how to future-proof digital quality systems.
Key learning objectives include:
Applying ICH E6 (R3) principles to electronic and hybrid trial models.
Strengthening data governance, audit trails, and vendor oversight.
Implementing effective system validation and ALCOA+ data integrity controls.
Identifying and mitigating technology-driven quality risks.
Reviewing real-world inspection findings and best-practice remediation strategies.
An interactive workshop on AI/ML tools and Critical to Quality factors will complement the sessions, helping professionals apply concepts directly to their operational environments.
All attendees will receive a Certificate of Completion from Fleming Events, validating their enhanced digital GCP competence.
This initiative reflects Fleming Events’ long-standing commitment to supporting life-science professionals with practical, regulator-informed learning experiences that strengthen quality culture and compliance across global clinical research.
About Fleming Events:
Fleming Events is a global leader in organizing high-level conferences, training courses, and summits across industries including life sciences, energy, finance, and technology. For over two decades, Fleming has been connecting professionals worldwide through practical learning and business knowledge exchange.
The training comes at a critical time as regulators worldwide increase their focus on Good Clinical Practice (GCP) compliance, data integrity, and the validation of electronic systems under the updated ICH E6 (R3) guideline. The new framework redefines how sponsors, CROs, and investigators must ensure quality and reliability in digital and decentralized clinical trials.
“Digital transformation is changing how trials are conducted, and compliance expectations are evolving just as quickly,” said a spokesperson for Fleming Events. “This course equips professionals with the knowledge and tools needed to align digital systems, data workflows, and vendor oversight with the new ICH E6 (R3) requirements.”
The two-day training will be led by a former MHRA Group Manager and member of the ICH E6 (R3) Expert Working Group, together with a Digital Clinical Trials Innovator. Through a mix of case studies and regulatory insights from EMA, MHRA, and FDA inspections, participants will gain a clear understanding of how to future-proof digital quality systems.
Key learning objectives include:
Applying ICH E6 (R3) principles to electronic and hybrid trial models.
Strengthening data governance, audit trails, and vendor oversight.
Implementing effective system validation and ALCOA+ data integrity controls.
Identifying and mitigating technology-driven quality risks.
Reviewing real-world inspection findings and best-practice remediation strategies.
An interactive workshop on AI/ML tools and Critical to Quality factors will complement the sessions, helping professionals apply concepts directly to their operational environments.
All attendees will receive a Certificate of Completion from Fleming Events, validating their enhanced digital GCP competence.
This initiative reflects Fleming Events’ long-standing commitment to supporting life-science professionals with practical, regulator-informed learning experiences that strengthen quality culture and compliance across global clinical research.
About Fleming Events:
Fleming Events is a global leader in organizing high-level conferences, training courses, and summits across industries including life sciences, energy, finance, and technology. For over two decades, Fleming has been connecting professionals worldwide through practical learning and business knowledge exchange.
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Fleming Events
Karthik Naik
00421911820365
fleming.events/
Karthik Naik
00421911820365
fleming.events/
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