Medicon Valley Alliance and Suvoda would like to welcome you to a Good Morning Meeting 8th of September 2026.
Good Clinical Practice has just completed its biggest overhaul in 25 years. ICH E6(R3) Principles and Annex 1 took effect in July 2025, and in June 2026 the ICH Assembly completed the framework by adopting Annex 2—the new global standard for decentralized trials, real-world data, and pragmatic study designs. The revised guidance introduces a more flexible, risk-based approach to clinical trial conduct and encourages fit-for-purpose processes supported by purpose-built technology.
“How does this translate into my day-to-day role in setting up and managing clinical trials?”
Implementing ICH E6 (R3) is not just about compliance; it is an opportunity to elevate the standard of clinical research. The guideline encourages organizations to think more critically about trial design and to leverage technology more effectively to reduce operational burden for sponsors, sites, and patients — while keeping the patient at the center of every decision.
Topics covered include:
• Key updates and expectations within ICH E6 (R3)
• Risk-based trial management
• Patient-centric clinical trial operations
• The role of modern digital technologies in supporting trial execution
The session is designed for professionals and leaders working within Clinical Operations, Clinical Trial Supply, Data Management, Quality, and related clinical development functions.
Date: Tuesday 8th of September 2026
Time: 8:30 – 11:30
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Hub 2
Program
| 8:30 | Networking, registration and breakfast |
| 9:30 | Welcome and introduction to Medicon Valley Alliance David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance |
| 9:35 | Welcome and introduction to Suvoda Chris Copeland, Director Sales, Suvoda |
| 9:40 |
Translating regulatory expectations into practical steps and exploring how purpose-built technology can help organizations operationalize the guideline. |
| 11:30 | End of Good Morning Meeting |
Speakers
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Henk Dieteren, Clinical Supply Chain Solutions Consultant, Suvoda
As a Clinical Supply Chain Solutions Consultant, he currently provides expertise to Suvoda in various aspects of clinical trial supply management. Prior to joining Suvoda, he co-founded the clinical trial supplies department at Grünenthal GmbH, where he served as Associate Director for 10 years. During his time at Grünenthal, he developed operational processes and implemented risk management procedures that helped establish the company as a leader in the clinical supply chain market. More recently, he worked as a Senior Investigational Medicinal Product Manager at BioNTech SE, where he streamlined data processing operations within the clinical supply chain for personalized oncology therapies. He is an innovative expert in IRT, temperature excursion management, and direct-to-patient logistics. |
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Joachim Lövin, DCT Specialist, Independent Consultant
Joachim is a DCT and digital health specialist with over two decades of sponsor-side experience in global clinical development. At Novo Nordisk, he built the internal DCT framework adopted across the full development organization and led the TransCelerate Modernizing Clinical Trial Conduct workstream with contributors from up to 15 pharmaceutical companies. The output was a suite of publicly available process frameworks now embedded in industry practice. His work sits at the intersection of regulatory reality and operational practicality. He knows what DCT looks like on paper and what it takes to make it work in a real trial. |
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