Virtual Quality Working Party’s Pre-Workshop
EFGCP Conference 2026
Driving Quality and Compliance in a Changing Clinical Research World
In recent years, the clinical research environment has been shaped by significant regulatory, ethical, and technological change. Updates such as ICH E6(R3), evolving expectations around risk management and quality oversight, and the growing use of digital tools and artificial intelligence are redefining how clinical trials are designed, conducted, and supervised. While these developments aim to strengthen participant protection and data integrity, they also introduce new complexity for sponsors, investigators, auditors, and regulators alike.
The Quality Working Party Workshop provides a dedicated forum to explore these changes from a practical, cross-stakeholder perspective. Through open discussion and expert-led sessions, the workshop focuses on how new requirements can be implemented in a risk-proportionate and effective way, how inspection and oversight practices are evolving post-COVID, and how emerging ethical and technological challenges can be addressed without compromising quality or trust.
By creating space for open exchange and shared learning, the QWP Workshop aims to support consistent interpretation, pragmatic implementation, and continuous improvement in clinical research quality systems, laying the groundwork for more efficient, ethical, and sustainable trials in Europe and beyond.
This Virtual Pre-Conference Workshop is part of the EFGCP Conference 2026. You can attend it for free by registering to the EFGCP Conference 2026.
With the Support of
Programme
| 13.00 |
Welcome to QWP Open Forum
Maria Veleva, Velev Consulting Ltd.
Mark Poulton, Poulton Quality Solutions Ltd
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| 13.15 |
Opening Address
Ingrid Klingmann, EFGCP
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| 13.30 |
Understanding ICH E6(R3) Changes from an Auditor’s Perspective and Applying them in Practice
Shaun Hastings, PHARMExcel
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| 14.30 |
What has changed since COVID-19 in relation to GCP Inspections?
Manos Papadakis, National Organization for Medicines
Thania Aileen Spathopoulou, European Medecines Agency
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| 15.30 |
Break |
| 15.45 |
US Administration: Effect on US and Global Research
Michelle Holbrook, Stemline Therapeutics
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| 16.45 |
Key Concepts in the 2022 FDA Draft Guidance on Pediatric Research Ethics
Robert “Skip” Nelson, J&J Innovative Medicine
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| 17.45 |
Questions and Answers |
| 17.50 |
Close of the Day |
| 09.00 |
Welcome & Introduction
Maria Veleva, Velev Consulting Ltd.
Mark Poulton, Poulton Quality Solutions Ltd
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| 09.15 |
Root Cause and Bias
Fatemeh Jami, Worldwide Clinical Trials
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| 10.00 |
Artificial Intelligence in Clinical Trials and Auditing, effects in different regions
Meelis Lootus, Tehistark
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| 10.45 |
Break |
| 11.00 |
How do issue management and centralised monitoring fit together with risk-based quality management?
Keith Dorricott, Dorricott Metrics & Process Improvement Limited
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| 11.45 |
Wrap Up and Close
Maria Veleva , Velev Consulting Ltd
Mark Poulton , Poulton Quality Solutions Ltd
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| 12.00 |
Close |
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- Transition to EFGCP Conference 2026 - |
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