Image of Rotterdam DIA2026

💡Are you ready for #DIAEurope2026? 🙌 We are!

On Tuesday:
☑️Our executive director is on the opening session panel
⌛ 08:30 - 10:00
📍 ROTTERDAM - A (3rd Floor)

☑️ Hear from the BRIDGE project about regulatory sandboxes
⌛13:30 - 14:40
📍ROTTERDAM - A (3rd Floor)
#RegulatoryScience #HorizonEU #Health

Check out this article by @nicolascreff.bsky.social on how IHI is driving progress, in fields from #AMR to #HeartDisease, #BigData, #RegulatoryScience and more! #Health #Research #PublicPrivatePartnerships #IHITransformingHealth

RecovryAI wins FDA Breakthrough Designation for post-surgical AI platform | Medical Economics Virtual care assistant targets gap in outpatient recovery monitoring as same-day procedures shift clinical oversight burden

🚀 RecovryAI wins FDA Breakthrough Device Designation for its AI virtual assistant supporting post-surgical recovery.
As outpatient surgeries rise, AI-driven remote monitoring may help reduce complications and readmissions.
Read more below.
#AIinHealthcare #DigitalHealth #SaMD #RegulatoryScience

Portugal recebe primeiro ensaio clínico da iniciativa FAST-EU Infarmed

🔬 Portugal recebe primeiro pedido de autorização de ensaio clínico no âmbito do projeto europeu FAST-EU

Aceda à notícia na íntegra em: 🔗 swki.me/gh9rFhhs

#infarmed #ensaiosclínicos #clinicaltrials #FASTEU #CTIS #regulatoryscience #EU #investigacaoclínica

The R Consortium Submissions Working Group is making “all-R” regulatory submissions more practical through real pilots and regulator feedback.

If you work in clinical trials / submissions / validation, get involved! r-consortium.org/posts/submis...

#clinicaltrials #regulatoryscience

FDA researcher urges performance‑based evaluation and clear regulatory pathway for emerging anti‑biofilm technologies Summarizing two WEAC projects, Dr. Jelika Amarsingh said electrical stimulation and photothermal gold‑nanorod coatings show promise for reducing early biofilms but require performance standards, clinical validation, corrosion and tissue‑safety testing, and a regulatory pathway before clinical adoption.

Dr. Jelika Amarsingh calls for urgent regulatory reforms to tackle the staggering 100,000 annual deaths linked to device-associated biofilm infections and highlights promising breakthroughs in anti-biofilm technology.

Click to read more!

#US #CitizenPortal #PublicHealth #RegulatoryScience

A career in Regulatory Affairs

A career in Regulatory Affairs

https://zpr.io/VTgMaQcMAtvZ

#RegulatoryAffairs #PharmaceuticalRegulations #ComplianceCareers #RegulatoryScience #DrugDevelopment #careers #jobs #pharma #pharmiweb

Search Jobs in Pharma: https://phrmwb.com/careers

✨ We’re proud to have #AGES on board, helping us navigate the regulatory landscape and paving the way for trustworthy, future-proof AI-driven imaging technologies.

#AutoPiX #RegulatoryScience #AIinHealthcare #MDR #IVDR #MedicalDevices #DigitalHealth #Innovation #IHI

Today, @ihieurope.bsky.social hosted a webinar on regulatory impact. On behalf of AMYPAD, Gill Farrar presented how we succeeded in the Biomarker Qualification Opinion application for our Centiloid work!

#RegulatoryScience #HorizonEurope #ResearchImpact

Meet the speakers: Ralf Herold, Thorsten Vetter, Silvy Da Rocha Dias, Christina Giannakou, Pierpaolo Moscariello and Oriane Blanquie from the EMA, Gill Farrar from GE Healthcare, Pieter Annaert from KU Leuven and BioNotus, and Marco Viceconti and Giorgio Davico from the University of Bologna

🚨 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! 👉 link.europa.eu/vGdQrY
#RegulatoryScience #HorizonEurope

Regulatory impact: what it is and how to achieve it with your IHI project 10.12.2025 14:00-16:00 Brussels time Online event Learn how to maximise your project’s regulatory impact. Hear from the regulators and past projects about their experiences and tips on how to achieve regulatory goals.

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

Yesterday, the 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐒𝐜𝐢𝐞𝐧𝐜𝐞 𝐍𝐞𝐭𝐰𝐨𝐫𝐤 𝐍𝐞𝐭𝐡𝐞𝐫𝐥𝐚𝐧𝐝𝐬 (𝐑𝐒𝐍𝐍) marked its 10-year anniversary during the Annual Workshop.
🔍This year’s theme was 𝐒𝐢𝐧𝐠𝐥𝐞 𝐀𝐫𝐦 𝐓𝐫𝐢𝐚𝐥𝐬 (𝐒𝐀𝐓𝐬).
🙌𝐅𝐫𝐚𝐧𝐤 𝐇𝐮𝐥𝐬𝐭𝐚𝐞𝐫𝐭 𝐫𝐞𝐩𝐫𝐞𝐬𝐞𝐧𝐭𝐞𝐝 𝐊𝐂𝐄 as one of the speakers.
🎈Congratulations to RSNN!

#RegulatoryScience #RSNN #KCE #KCETrials

The explainable aging clock regulators might actually like - Biotech Industry Examiner A new bioRxiv preprint introduces ACE—Aging Cell Embeddings—an explainable, deep-generative model that claims to pull out universal transcriptional signatures

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
biotech.industryexaminer.com/explainable-...
#TechNews #biomarkers #ExplainableAI #RegulatoryScience #Biotech

Join us on 10 Dec for Regulatory Impact: What it is and how to achieve it.

🔬 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 @ema.europa.eu regulators & past projects
👉 link.europa.eu/vGdQrY
#IHITransformingHealth #HealthResearch #EUResearch #RegulatoryScience

Welcome! You are invited to join a webinar: Best Digital Health Webinar #1. After registering, you will receive a confirmation email about joining the webinar. The Galien Foundation is proud to present the 2025 Galien Week of Innovation, which is a series of webinars showcasing this year’s award nominees and their groundbreaking innovations. With the surge ...

Happening in 15 minutes: join us, @boehringerglobal.bsky.social & our fellow nominees for The Galien Foundation's Week of Innovation. Learn how we're streamlining regulatory review so therapies can be accessed by patients faster.

Register Now: hubs.ly/Q03Qlxcw0

#PrixGalienUSA #RegulatoryScience

Welcome! You are invited to join a webinar: Best Digital Health Webinar #1. After registering, you will receive a confirmation email about joining the webinar. The Galien Foundation is proud to present the 2025 Galien Week of Innovation, which is a series of webinars showcasing this year’s award nominees and their groundbreaking innovations. With the surge ...

Tomorrow: join us & @boehringerglobal.bsky.social for The Galien Foundation's Week of Innovation! Learn about our 2025 Prix Galien nominee which is enabling faster decisions and democratizing access to therapies worldwide.

Register now: hubs.ly/Q03Q2x030

#PrixGalienUSA #RegulatoryScience

Citizen Petition Stirs Loper Bright Decision Into Convincing FDA To Allow 118 Health Claims Alliance of Natural Health launches initiative to change FDA’s use of “significant scientific agreement” standard for allowing health claims with a citizen petition for approval of 118…

A new citizen petition, backed by the Loper Bright SCOTUS ruling, could force the FDA to allow 118 new nutrient-disease claims, even if the science is shaky.

#CosmeticScience #FDA #Supplements #HealthClaims #LoperBright #RegulatoryScience buff.ly/4QllLyj

New paper in Nature Reviews Drug Discovery highlights how to maximise the regulatory impact of consortium-based projects The paper, by authors from IHI and the Critical Path Institute, highlights the importance of a structured, strategic approach to regulatory issues from the beginning.

🏛️ Helping projects achieve regulatory impact is the topic of today’s #IHISummerOfScience story. Writing in @natrevdrugdiscov.nature.com, authors from IHI and @cpathinstitute.bsky.social offer their advice to consortia

👉 europa.eu/!nKyFyQ

#IHITransformingHealth #HorizonEU #RegulatoryScience

This is a team effort 🤝. To keep Europe at the forefront of food safety and innovation, we need the best science and contributions from stakeholders— 🔢 data, 📖knowledge on 👩‍🔬 biotech processes, and more.

🇪🇺🔬💡 #FoodSafety #Biotechnology #RegulatoryScience #Innovation

#PublicHealth #IFPH2025 #ThomasAshtonInstitute #RiskResearch #RegulatoryScience #UoM #HealthAndSafety #HealthInnovation

🤝 Interested in applying PSA to your own chemical portfolio? Let’s connect and chat!
#OpenAccess #ExposureLed #NGRA #ChemicalSafety #NAMs #PBK #RiskAssessment #Toxicology #RegulatoryScience

Collage featuring the Thomas Ashton Institute logo on a blue background, surrounded by images representing risk and regulatory research: an industrial robotic arm, scientists in lab coats in discussion, wind turbines in a field, thick ropes, and masked healthcare professionals.

🚨 Just released!
The latest edition of our newsletter is now live — packed with updates on our research into risk, regulation, and workplace safety.

👉 Read it here: bit.ly/44l9bRL

#ThomasAshtonInstitute #RiskResearch #RegulatoryScience #UoM #HealthAndSafety

Quantitative LC-QToF-MS Analysis of Mycochemicals in Amanita muscaria, Psilocybe spp. (Agaricomycetes), and Consumer Products

dl.begellhouse.com/journals/708...

#PsychedelicMushrooms #Mycology #RegulatoryScience

Quantitative LC-QToF-MS Analysis of Mycochemicals in Amanita muscaria, Psilocybe spp. (Agaricomycetes), and Consumer Products

dl.begellhouse.com/journals/708...

#PsychedelicMushrooms #Mycology #RegulatoryScience

Big Challenges Remain for Nanomaterials Under REACH.

REACH compliance for nanomaterials isn't straightforward, but is achievable...

www.bluefrogscientific.com/c...

#Nanomaterials #Nanoforms #REACHCompliance #ChemicalRegulation #NanoRegulation #RegulatoryScience #RegulatoryStrategy

📢 JUST PUBLISHED: Paper in @natrevdrugdiscov.nature.com on how to maximise #RegulatoryImpact from public-private partnerships, co-authored by IHI’s Nathalie Seigneuret. Check out 3 examples to follow from C-Path & @imi-amypad.bsky.social
👇 Read it below 👇
#IHITransformingHealth #RegulatoryScience

I look forward to the educational opportunities at this meeting. Special thanks to Gillian Schauer and her team for putting it together! 🧵 2/2
#CannabisSafety #RegulatoryScience

ABSTRACT We perform bibliometric analysis on documents for 255 Regulatory Impact Analyzes (RIAs) prepared by the US Environmental Protection Agency (EPA) from 1980 through 2024. Using a series of automated information extraction methods, we extract references from these documents and match them to bibliographic records. We then build a database of relevant articles (whether cited in an RIA or not) and fit a two-stage regression model that predicts whether, and how many times, a reference is used in RIAs as a function of journal prestige, professional popularity, article accessibility, EPA funding, and involvement of EPA employees as co-authors. By considering cited and uncited articles related to similar scientific concepts, we can observe systematic differences in what types of research products get used in policy analysis. Academic popularity, open access status, and EPA authorship and sponsorship all predict more likely and more frequent article use. Articles in prestigious journals are no more likely to be referenced, but once referenced in the corpus are then referenced more frequently.

#Earlyview #Openaccess

'The Drivers of Science Referenced in US EPA Regulatory Impact Analyses: Open Access, Professional Popularity, and Agency Involvement'
By: Tyler A. Scott, Sojeong Kim, Liza Wood

See abstract below 👇

#RegulatoryScience #RegGov

onlinelibrary.wiley.com/doi/10.1111/...

Comment to talk to us!
#ClinicalResearch #TherapyDevelopment #RegulatoryScience #NewProductDevelopment

💻 Missed the REMEDi4ALL academic bootcamp? Catch up with new content now available in our Digital Academy!

📚 The Regulation module has fresh insights on regulatory frameworks + engaging with regulators.

🔗 loom.ly/3UeBnjA

#RegulatoryScience #DigitalAcademy