Mastodawn

🚨 Happening today! Join us at 14:00 for Regulatory impact: what it is & how to achieve it with your IHI project. Hear from EMA regulators & past projects about their experiences, advice & top tips for achieving maximum impact. Don't miss it! 👉 https://link.europa.eu/vGdQrY
#RegulatoryScience #HorizonEurope

Industry Examiner Dec 9

The FDA has qualified AIM-NASH, the first AI histology tool used as a drug-development endpoint, to read liver biopsies in MASH trials. What happens when an algorithm helps decide if a drug works?
https://biotech.industryexaminer.com/fda-aim-nash-ai-liver-biopsy-mash-trials/
#biotech #AIinBiotech #liverdisease #MASH #digitalpathology #clinicaltrials #regulatoryscience #TechNews

When the FDA Starts Trusting Algorithms: What AIM-NASH Means for Liver Drug Trials - Biotech Industry Examiner

On 8 December 2025, the US Food and Drug Administration (FDA) tried to change that. It qualified AIM-NASH – an AI-based histology system developed by PathAI –

Biotech Industry Examiner

Innovative Health Initiative Dec 3

👩‍🔬 What is #RegulatoryImpact and how can your project achieve it?
👉 Join us online on December 10 at 14:00 and find out!
💡 Hear from European Medicines Agency experts plus researchers from projects who've already smashed their #RegulatoryScience goals.
👉 Register and find out more: https://link.europa.eu/vGdQrY
#IHITransformingHealth #HealthResearch #ResearchImpact

Innovative Health Initiative Nov 19

🙋‍♀️ Are you part of a research project under IMI or IHI (or any other research project where regulatory aspects could be important)?
💡 Do you want to understand what regulatory impact is and how to achieve it?
👉 Join us on 10 December for this online event and seize the opportunity to hear from the European Medicines Agency experts about the best ways for projects to engage with regulators.
✒️ Sign up: https://link.europa.eu/vGdQrY
#IHITransformingHealth #HorizonEU #RegulatoryScience

Industry Examiner Nov 11

Explainable > black box. ACE could give #longevity its first regulator-friendly ageing readout: pathway-level features, pre-specified Context of Use, and a credible validation plan. Our take
https://biotech.industryexaminer.com/explainable-aging-clock-ace-regulatory-biomarker-roadmap/
#TechNews #biomarkers #ExplainableAI #RegulatoryScience #Biotech

Innovative Health Initiative Nov 10

🔬 Do you want to better understand what #RegulatoryImpact means & how to achieve it with your IMI or IHI project? 🚀 Join us on 10 Dec at 14:00 & find out! Hear from European Medicines Agency regulators & past projects
👉 https://link.europa.eu/vGdQrY
#IHITransformingHealth #HealthResearch #EUResearch #RegulatoryScience

CSBJ Aug 15

🧪 Can AI revolutionize how we test chemicals for skin safety—without animal experiments?

🔗 SbD4Skin by EosCloud: Integrating multi-view molecular representation for predicting skin sensitization, irritation, and acute dermal toxicity. DOI: https://doi.org/10.1016/j.csbj.2025.08.001

📚 CSBJ Nanoscience and Advanced Materials: https://www.csbj.org/nano

#Toxicology #AI #SkinSafety #MachineLearning #Cosmetics #SbD4Skin #NoAnimalTesting #FAIRdata #Chemoinformatics #RegulatoryScience #QSAR #CSBJNAM @csbj

Winbuzzer May 8, 2025

OpenAI & FDA Discuss AI Role in Drug Evaluation

#AI #OpenAI #FDA #DrugDiscovery #RegulatoryScience #HealthTech #Biotech #GovTech

https://winbuzzer.com/2025/05/08/openai-fda-discuss-ai-role-in-drug-evaluation-xcxwbn/

Innovative Health Initiative Oct 15, 2024

📢 Just published - the report of our regulatory science summit, where experts from regulatory organisations and other stakeholders explored how IHI, as a cross-sector, public-private partnership, can contribute to #RegulatoryScience. Attendees also explored how to maximise the regulatory impact of IHI projects.
👉 Read more: https://europa.eu/!MF7YN3
#IHITansformingHealth #HorizonEU

IHI Regulatory Science Summit Report published

The report summarises the discussions and main takeaways of the IHI Regulatory Science Summit held earlier in 2024.

IHI Innovative Health Initiative

Ralf HEROLD Aug 27, 2024

Inviting mid-career life science academics to a secondment to the European Medicines Agency: help us advance working with academia for accelerating the translation of academia-originating solutions into medicinal products, drug development tools and regulatory science progress!

Applications welcome until 30 September 2024. Details: https://careers.ema.europa.eu/job/Amsterdam-SNEScientific-Specialist-%28science-&-regulation%29/1111848701/

#medicines #research #publichealth #regulatory #science #regulatoryscience #clinicalresearch #methodsresearch #lifesciences

When the FDA Starts Trusting Algorithms: What AIM-NASH Means for Liver Drug Trials - Biotech Industry Examiner

IHI Regulatory Science Summit Report published

SNE/Scientific Specialist (science & regulation)