eCF Views:
What’s new in the world of clinical research? Any topics you are you currently discussing, or questions that are keeping you up at night? Share them with your fellow eCF members on our eCF Discussion Forum.
1. SAVE THE DATE: Joint FDA/MHRA/Health Canada GCP Symposium — June 2026
The triennial joint regulatory symposium returns 2–4 June 2026, with FDA, MHRA, and Health Canada examining ICH E6(R3) implementation, the cultural shift from compliance-driven to quality-focused trial conduct, bioequivalence, and pharmacovigilance. This is one of the most substantive opportunities to hear directly from inspectors across three major jurisdictions — insights from the 2024 edition on quality-by-design, sponsor oversight, and data governance have since been published in Clinical Pharmacology & Therapeutics. For GCP auditors and eClinical professionals, this one is worth the diary entry. 🔗 Regulatory Perspectives in GCP, Bioequivalence and GPvP — FDA Event Page | 2024 Symposium Summary — Clin Pharmacol Ther, Wiley (2025)
2. ICH E6(R3) in Practice: What GCP Now Actually Requires
Published in Clinical Researcher (ACRP, February 2026), a detailed analysis of the FDA's E6(R3) guidance confirms that the updated standard requires sponsors to ensure personnel at CROs, sites, and service providers are all trained on GCP practices, trial protocols, and their specific roles - a new and explicit requirement for research sites. For QA professionals, this is a vendor oversight and audit finding waiting to happen. Training documentation chains now extend well beyond the sponsor's own organisation. 🔗 Galio H. Clinical Researcher, Vol. 40, Issue 1, February 2026. ACRP
3. AI in Drug Development: FDA Guidance Under the Microscope
A critical review published in the Journal of Chemistry (Wiley, February 2026) identifies a significant gap in the FDA's AI guidance framework: AI systems used across multiple phases of development - from target identification through clinical trial design - create regulatory ambiguity that the current guidance leaves unresolved. Compared to EMA's broader lifecycle approach, the FDA's narrower scope risks divergent requirements for globally operating sponsors, worth monitoring as both agencies move toward binding guidance. 🔗 Niazi S et al. Journal of Chemistry 2026. DOI: 10.1155/joch/5202999
4. GAMP 5 & E6(R3): Vendor Computerised Systems Now Firmly in the Audit Frame
The January/February 2026 issue of ISPE Pharmaceutical Engineering highlights that regulatory audits are increasingly targeting service providers, particularly where computerised systems manage essential documentation or trial-critical processes, and that SOPs must do more than simply exist on paper, they must reflect ISPE GAMP 5 Second Edition as current industry best practice. The practical implication for eClinical vendors is blunt: outdated validation documentation is now an audit liability shared with the sponsor, and qualification frameworks need to reflect this. 🔗 ISPE Pharmaceutical Engineering, January/February 2026 (Paywall)
These articles are not endorsed by the eCF and don’t necessarily represent our own views
eCF News:
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Are you curious about Audit Trail Review and its real-world implications? After last month’s public release of the industry position paper "Strategies for implementing Audit Trail Review“, the eCF Audit Trail Review team is presenting a public webinar on Thursday, March 19, at 1:00 pm UTC, to walk through the paper’s key ideas and implementation approach. This webinar is accessible to both eCF members and the general public - this is a great opportunity to get some insights both into current developments in Audit Trail Review and the eClinical Forum!! Sign up
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Registration for the 2026 Spring Workshops are now open! Don’t forget to register for this year’s spring workshops - both the Europe and APAC workshop are available for remote participation. A Workshop Agenda will follow soon. If you aren’t sure about your company’s seat availability or representative, please contact jana.summa@eclinicalforum.org
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APAC/Hybrid: Hosted by Novartis in Tokyo, Japan on April 2-3. Sign up
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Europe/ Hybrid: Hosted by Servier outside of Paris on April 14-16 (this will be livestreamed as well). Sign up
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Americas: Hosted by YPrime outside of Philadelphia, PA on April 28-30. Sign up
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We are still looking for exciting, innovative workshop topics for our Spring Workshops, especially in the field of AI in Clinical Research. If you have suggestions and ideas, contact one of our facilitators below! (Sean Higashio for APAC, Tom Haag for Americas, Jana Summa for Europe)