#regulatoryscience — Public Fediverse posts

❗ The HEU-EFS project has launched an evidence-based framework to demonstrate how early feasibility studies can best be carried out and assessed in Europe.
Now, the project is launching pilots 🚀 to test out the framework.
👉 https://bit.ly/4fP7vXy
#MedTech #EFS #RegulatoryScience

❗ The HEU-EFS project has launched an evidence-based framework to demonstrate how early feasibility studies can best be carried out and assessed in Europe.
Now, the project is launching pilots 🚀 to test out the framework.
👉 https://bit.ly/4fP7vXy
#MedTech #EFS #RegulatoryScience

👋 Meet Aurora Signorazzi - passionate about alternatives to animal testing 🐾
She carried out her PhD in #3Rs in #vaccines as part of VAC2VAC & went on to have a successful career in the pharma industry & medical regulation.
👉 https://link.europa.eu/9DrdtQ
#ResearchCareers #HealthResearch #RegulatoryScience #EU #Health #Innovation

👋 Meet Aurora Signorazzi - passionate about alternatives to animal testing 🐾
She carried out her PhD in #3Rs in #vaccines as part of VAC2VAC & went on to have a successful career in the pharma industry & medical regulation.
👉 https://link.europa.eu/9DrdtQ
#ResearchCareers #HealthResearch #RegulatoryScience #EU #Health #Innovation

💡Are you at #DIAEurope2026 today? Us too!

✅ PharmaLedger: electronic product info
⌛12:05-12:35📍DOCK 16, Floor 2

✅ Gravitate-Health: enhancing how people receive health info
⌛15:00-16:10📍ROTTERDAM A, Floor 3

✅ READI: boosting representativeness in clinical research
⌛15:00-16:10📍DOCK 13, Floor 2

#Health #Research #EU #RegulatoryScience

💡Are you at #DIAEurope2026 today? Us too!

✅ PharmaLedger: electronic product info
⌛12:05-12:35📍DOCK 16, Floor 2

✅ Gravitate-Health: enhancing how people receive health info
⌛15:00-16:10📍ROTTERDAM A, Floor 3

✅ READI: boosting representativeness in clinical research
⌛15:00-16:10📍DOCK 13, Floor 2

#Health #Research #EU #RegulatoryScience

💡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 #Research #EU #Science

💡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 #Research #EU #Science

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 and want to help, get involved: https://r-consortium.org/posts/submissions-wg-2026

#rstats #clinicaltrials #regulatoryscience #pharma #opensource

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 and want to help, get involved: https://r-consortium.org/posts/submissions-wg-2026

#rstats #clinicaltrials #regulatoryscience #pharma #opensource

🚨 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

🚨 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

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

👩‍🔬 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

👩‍🔬 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

🙋‍♀️ 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

🙋‍♀️ 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

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

🔬 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

🔬 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

🧪 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

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/

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/

📢 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

📢 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

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

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

Tool improved for exploring #Medicines #RegulatoryScience: added document-level combinations of queries into text units of European Public Assessment Reports (EPARs) - many thanks to Marcia Rückbeil for the question. See 'Assessment analysis' at https://paediatricdata.eu/emaepars/

Tool improved for exploring #Medicines #RegulatoryScience: added document-level combinations of queries into text units of European Public Assessment Reports (EPARs) - many thanks to Marcia Rückbeil for the question. See 'Assessment analysis' at https://paediatricdata.eu/emaepars/

Inviting experts in life sciences to apply for secondment to the European Medicines Agency on #academia engagement and #regulatoryscience #research! We're a great small team supporting academic researchers & developers and advancing regulatory standards & practices. Deadline 3 June. More here: https://careers.ema.europa.eu/job/Amsterdam-SNEScientific-Specialist-%28science-&-regulation%29/1067214901/

Inviting experts in life sciences to apply for secondment to the European Medicines Agency on #academia engagement and #regulatoryscience #research! We're a great small team supporting academic researchers & developers and advancing regulatory standards & practices. Deadline 3 June. More here: https://careers.ema.europa.eu/job/Amsterdam-SNEScientific-Specialist-%28science-&-regulation%29/1067214901/

RT by @EU_Health: Happy 29th anniversary EMA 🎉 Working for public and animal health across 🇪🇺 since 1995.

https://www.youtube.com/watch?v=UJl-NPMy8oQ

#PublicHealth #RegulatoryScience #Innovation #medicines #patients #anniversary

🐦🔗: https://nitter.cz/EMA_News/status/1750791239102812194#m

[2024-01-26 08:02 UTC]

RT by @EU_Health: Happy 29th anniversary EMA 🎉 Working for public and animal health across 🇪🇺 since 1995.

https://www.youtube.com/watch?v=UJl-NPMy8oQ

#PublicHealth #RegulatoryScience #Innovation #medicines #patients #anniversary

🐦🔗: https://nitter.cz/EMA_News/status/1750791239102812194#m

[2024-01-26 08:02 UTC]

#Introductions
I like and care about:
#Microglia
#Microbiota
#Neurodevelopment
#Neuroimmunology
#GutBrainMicrobeAxis
#GutBrainAxis
#SciencePolicy
#RegulatoryScience
#RegulatoryPolicy
#TeaAndBiscotti
I am concerned about:
#COVID
#LongCovid

#Introductions
I like and care about:
#Microglia
#Microbiota
#Neurodevelopment
#Neuroimmunology
#GutBrainMicrobeAxis
#GutBrainAxis
#SciencePolicy
#RegulatoryScience
#RegulatoryPolicy
#TeaAndBiscotti
I am concerned about:
#COVID
#LongCovid