Where the thinking currently is.
Notes are iFeed's working surface for current thinking — what the regulator just published, what the deployment patterns actually look like, what the methodology produces under real conditions. The cadence is regular but unhurried; depth matters more than frequency.
Vaccine and antidote: the missing vocabulary for AI in regulated life sciences.
Why immunity is the right model, not insulation. The three phases of organisational immunity to AI failure modes, and why the regulatory clock just struck noon.
iFeed Weekly · W22: 25–31 May 2026.
Nine source-backed signals across structured protocols, real-time clinical trials, AI Act classification, real-world evidence, QMSR readiness, device data, ML-enabled device lifecycle control, and the first iFeed Regulations artifact.
iFeed Weekly · W21: 18–24 May 2026.
Nine official-source signals across EU AI Act classification, FDA TEMPO, ACT EU trial metrics, AI in GMP, real-time trials, UDI execution, food-effect evidence, lifecycle quality and oral GLP-1 market movement.
iFeed Weekly · W20: 11–17 May 2026.
Nine selected signals across clinical trials, AI governance, IDMP, QMSR, biomarker validation, bioequivalence, non-animal evidence, pharmacovigilance and product-specific BE.
iFeed Weekly · W19: 4–10 May 2026.
Nine updates across bioanalytical, bioequivalence, clinical trials, governance, AI in healthcare and broader. Verified primary sources. Click to open the full week — nine cards in a grid, full explanation below each.
Vaccine and antidote: the missing vocabulary for AI in regulated life sciences.
The framework regulated industries already have for absorbing agents that bring possibility and vulnerability — translated into AI deployment.
EU AI Act high-risk classification: worked example for a pharma AI inventory.
How to walk through Annex III against a real pharma company's AI footprint. What gets flagged, what doesn't, what the conformity assessment actually involves.
PCCP architectures for adaptive AI in medical devices.
What a Predetermined Change Control Plan should actually contain for an AI/ML system that is going to update. Reading the FDA guidance against current submissions.
GMP Annex 22 readiness: what the public consultation tells us.
Reading the draft Annex 22 alongside the EMA AI Reflection Paper. What pharma manufacturing should be doing now, before final publication in H2 2026.
Validation of non-deterministic systems: passing FDA inspection.
How IQ/OQ/PQ adapts when the system doesn't return identical output to identical input. Reference test sets, statistical envelopes, drift detection in practice.
ICH M11 structured-protocol: how AI changes the trial design layer.
The structured protocol template is becoming machine-readable. What that means for AI-assisted trial design, regulator review, and the eTMF lifecycle.
Bioanalytical method validation meets AI-augmented analysis.
What ICH M10 says about AI-touched chromatographic data. The audit-trail problem when a peak-integration model assists the analyst.
RSABE divergence post-ICH M13A: a practitioner's map.
The FDA-EMA divergence on highly variable drug scaling persists even with M13A in force. What sponsors filing in both regions still need to design around.
The 2025 483 pattern for bioanalytical: ISR, reagent-lot, partial validation.
FDA's top inspection findings in bioanalytical operations 2025. Why ISR sample-selection randomisation hit 28% and what to do about it before the next inspection cycle.
ICH E6 R3 principles-based GCP: the spirit, not the checklist.
R3 (Jan 2025) reframed GCP from prescriptive rules to outcome-based principles. What that means for sponsors, monitors, and auditors who built their muscle on R2.
ISO/IEC 42001 in pharma: what the AI management system standard actually requires.
The first international standard for AI governance. Reading 42001 against existing pharma QMS — where they overlap, where 42001 fills genuine gaps, and where the standard is too generic for regulated life sciences.
QMSR effective Feb 2026: the combination-product bridge that wasn't documented.
21 CFR 820 harmonised with ISO 13485. The DHF-to-BMV handshake that nobody pre-staged. Why it's becoming a top-5 483 category by 2027.
Governance as an immune system: why structure beats policy.
The architectural argument for treating quality governance as an active immune system rather than a static rule set. Why structure beats policy at the operational layer.
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Weekly cadence · Monday mornings. Each note a synthesis card from the practice — short, specific, governance-gated.