1. Preliminary Agenda and Registration Workshop 2026
Curious about this year’s workshop topics? Have a look at the Preliminary Agenda in the attachment below. Details are still being developed – if you are interested in presenting on any of the topics on the agenda or have your own topic you would like to speak on, contact one of our Facilitators (see email addresses below).
Whether you plan on attending in person or online, as a guest or as a speaker, don’t forget to register!
- Americas: 13.-15. October 2026, hosted by GenInvo in Bloomington, Illinois, USA. SIGN UP
- APAC/Hybrid: 21.-22. October 2026, hosted by Clario in Shanghai, China.SIGN UP
- Europe/Hybrid: 27.-29. October 2026, hosted by BSI Software in Zurich, Switzerland. SIGN UP
Anyone from our member companies can register for remote participation in the hybrid workshops for free, regardless of seat availability and location. For in-person attendance, each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative.
2. eCF Webinar: Exploring ICH E6 (R3) Annex 2 for Decentralized Trials and Real-World Data
Are you looking for an opportunity to share perspectives and explore the implications of Annex 2 for the future of clinical trials? Join our webinar on Wednesday, September 9 for a discussion on Annex 2 and its role in modernizing GCP to better reflect the evolving landscape of clinical research. The webinar will explore key considerations for Decentralized Clinical Trials (DCTs) and Real-World Data (RWD), including practical challenges and emerging requirements for data quality and oversight. The webinar will be held twice, at 3am EDT/9am CEST, and at 9am EDT/3pm CEST. Register here
eCF Views:
What’s new in the world of clinical research? Any questions you urgently need answers to, or topics that keep you up at night? Share them with your fellow eCF members on our eCF Discussion Forum.
1. E6(R3) Redistributes Data Governance Accountability - And the Inspection Data Explains Why
A late-July analysis argues that E6(R3)'s most consequential architectural change is elevating data governance into its own dedicated section: where E6(R2) housed data integrity expectations almost entirely within sponsor obligations, E6(R3) names both investigators and sponsors as responsible parties, closing a long-standing ambiguity that auditors flagged consistently. The FDA's own numbers make the case: in FY2024 the agency conducted 692 clinical investigator inspections and issued Form 483s in 23% of cases, with inadequate case histories among the leading deficiency themes. For site-facing eClinical systems, joint accountability changes what "adequate site training" and access controls need to demonstrate. 🔗 ICH E6(R3) Redistributes Data Governance Accountability — Clinical Trial Vanguard, July 2026
2. EMA's AI Reflection Paper: Frozen Models and Prespecified Pipelines
A recent analysis in Applied Clinical Trials unpacks EMA's position that applicants bear responsibility for ensuring all algorithms, models, datasets, and data processing pipelines are fit for purpose and aligned with GxP standards, and that where AI/ML models transform or analyse data, they are considered part of the statistical analysis and must follow applicable guidelines including impact on downstream inference. Most consequentially for late-stage development: EMA expects a prespecified data curation pipeline and a fully frozen set of models used for inference. "Frozen" is the operative word, continuously updating models are effectively off the table for pivotal analyses. 🔗 Harnessing AI in European Clinical Trials: Regulation in Progress — Applied Clinical Trials Online, July 2026
3. The AI Regulatory Landscape Is Genuinely Uneven - And That's the Story
A mid-2026 assessment describes the current state plainly: a detailed FDA framework still in draft form after more than a year, a finished EMA reflection paper that reads more as a statement of expectations than an enforceable rule, and an ICH process that has issued nothing AI-specific at all, leaning instead on general clinical trial principles recently rewritten in technology-neutral language. The FDA's seven-step, risk-based credibility assessment framework remains unfinalised as of mid-2026. For sponsors running global programmes, the practical takeaway is that "wait for harmonisation" is not a strategy. Build to the strictest applicable standard now. 🔗 Regulating AI in Drug Discovery: What FDA, EMA and ICH Guidance Means — Drug Discovery News, July 2026
These articles are not endorsed by the eCF and don’t necessarily represent our own views
eCF Views & News is a monthly newsletter of the eClinical Forum (www.eclinicalforum.org) to keep our members informed. Please feel free to forward this email to your colleagues. Please let us know if colleague(s) want to be added to this monthly distribution!
Your eCF facilitators are always interested in what you have to say …
Wolfgang.Summa@eClinicalForum.org, Sean.Higashio@eClinicalForum.org, Jana.Summa@eClinicalForum.org, Tom.Haag@eClinicalForum.org.