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What if clinical success is determined long before a candidate enters the clinic? Hear Roche and IQVIA Laboratories discuss how human-relevant biology, translational science and clinic-informed discovery can help prioritize candidates, reduce risk and strengthen the path from discovery to patient impact. November 19 | Register now: https://hubs.ly/Q04BrWq00

You’re invited. Complete Concierge Care is hosting two info sessions this November, and you’re welcome at either one. Come meet our physicians, hear how concierge primary care works, and ask us anything- about access, membership, or what day-to-day care actually looks like when your doctor isn’t watching the clock. In person: Wednesday, November 4, 5–7 PM · Hunter’s Bar and Grill, Potomac, MD Virtual: Tuesday, November 17, 6 PM · link sent after RSVP Both cover the same material, so just pick the one that works for you. We’d love to meet you.

How many tools does your team open to answer one question about EEG data? Recordings in one system, participant status in another, exports in a shared drive. NeuroJournal brings remote EEG, data review, export, and participant management into one platform. One login. One source. One less thing to reconcile.

Your digital endpoint is only as convincing as the data behind it. Repeated at-home EEG gives you more time points per participant, a better view of within-person variability, and measurements taken in participants' everyday environment. NeuroJournal brings EEG and cognitive data together in one platform for review and export. Let's talk about what your clinical trial needs.

وراء كل عينة، شخص ينتظر إجابة. مسارات العمل المختبرية الفعّالة تضمن وصول النتائج الدقيقة إلى الفرق السريرية في الوقت الذي تحتاجها فيه. من جمع عينة المريض، إلى التحليل الدقيق، إلى نتيجة يمكن الوثوق بها تدعم اتخاذ القرار. Erba LIMS يربط مختبرك برعاية صحية أكثر ترابطًا. احجز عرضك التجريبي.

كم ساعة يخسرها فريق مختبرك كل أسبوع في إدخال البيانات يدويًا؟ تكرار الإدخال، وتتبّع العينات على الورق، والمهام الإدارية المتراكمة، كلها تستنزف وقتًا ثمينًا كان يمكن تخصيصه لما يهم حقًا. مع Erba LIMS تتحول هذه الخطوات إلى سير عمل مؤتمت ومتكامل، ليتفرغ فريقك للعمل العلمي. احجز عرضك التجريبي اليوم.

Backed with $31.7M to predict drug safety in silico — and cut the industry's reliance on animal testing.

Should a pharmaceutical company invest in a dedicated statistical methodology group? On this week's "In the Interim…", Scott Berry talks with Jenny Devenport and Kaspar Rufibach of Merck Group, co-authors of the paper "Statistical Methodology Groups in the Pharmaceutical Industry," and May Mo of Amgen, a co-author of a US commentary on it. Highlights from the conversation: ✅️ Why a new method adds little until it is published, built into software, and scaled ✅️ How new mechanisms of action are pushing trial design beyond the t-test and log-rank test ✅️ Keeping methodologists and project statisticians working as one team ✅️ How one better phase 3 decision can pay for a methods group ✅️ Giving leadership design options, risks, and trade-offs instead of a single answer The full episode is live now: https://lnkd.in/gdUD5rJT

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A 30.6% hit rate across 80B compounds. Binding poses predicted to 1.2Å before the crystal structure existed. Outperforming AlphaFold3, Boltz-1 and Chai-1 on novel targets.

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MDR/IVDR Are Just the Tip of Your Regulatory Iceberg; Look Beyond Them A cornerstone of successful medical device development is identifying all regulatory requirements. The MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746) provide a vast catalog of device requirements and company procedures. Standards then offer additional details for compliance. However, many see this as the entire iceberg and assume it’s enough for full compliance. The reality is different. Medical devices and manufacturers often need to comply with multiple regulations. It’s crucial to identify all applicable regulations beyond the obvious ones. Here are 7 regulations and directives many miss but are often essential: EU AI Act (Proposal COM/2021/206) → Crucial for any medical device incorporating AI. → Adds a certification framework beyond MDR/IVDR. → Overlapping requirements mean a thorough gap analysis is essential. European Health Data Space Regulation (Proposal COM/2022/197) → Central to unlocking cross-border health data sharing in the EU. → A framework for primary and secondary use of electronic health data. → Compliance requires alignment with GDPR and national health laws. Radio Equipment Directive (2014/53/EU) → Applies to devices with wireless communication (e.g., Bluetooth). → EMC testing under MDR isn’t enough for compliance. → Requires additional IFU content, such as wireless frequency specifications. General Data Protection Regulation (Regulation (EU) 2016/679) → Applies to all devices interacting with personal data. → Covers even non-sensitive data, beyond health-related information. → Expected since its enforcement began in 2018. Battery Regulation (Proposal COM/2020/798) → Relevant for devices with rechargeable or disposable batteries. → Mandates user access to batteries for removal or replacement. → Requires compliance with labeling and recycling standards. RoHS (Directive 2011/65/EU) and REACH (Regulation (EC) No 1907/2006) → Limit hazardous substances in device materials. → Biocompatibility doesn’t guarantee compliance with these regulations. → Crucial during material selection for physical devices. WEEE (Directive 2012/19/EU) → Governs proper decommissioning and disposal of electrical devices. → Includes exemptions for implantable and potentially infectious devices. → Often Requires agreements with waste management organizations. By identifying them early, the iceberg may remain large, but at least you’ll have transparency and control. P.S. What other regulations or directives would you add to this list? ⬡⬡⬡⬡⬡⬡⬡ MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference. I'm Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed. Let's connect and collaborate to streamline regulatory work for everyone! #automation #regulatoryaffairs #medicaldevices

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No agro, uma grande rede credenciada é importante. Mas, para uma operação de grande porte, não é suficiente. Quando o investimento em saúde envolve muitas vidas, controlar custos, ter previsibilidade e flexibilidade também faz parte da gestão. A AUSTA Clínicas combina qualidade assistencial e proximidade com a gestão, para que sua empresa tenha mais controle sobre o plano e segurança para tomar decisões. Sua operação é grande. A gestão da saúde também precisa estar à altura. Fale com a AUSTA Clínicas. 👉 Conheça a Austa Clínicas: https://lnkd.in/d2AaHV_s

Jij wil toch ook werk waar je blij van wordt? Maak samen met jouw team én de bewoners van Het Prins Claushuis in Nijverdal een echt thuis. Niet zomaar een kleinschalige woonzorglocatie voor mensen met dementie, maar een plek waar iedereen zich prettig voelt en mag zijn wie hij of zij is. Weet jij als locatiemanager precies hoe je dat voor elkaar krijgt? Top! Bekijk de vacature op onze website.

Monitors from every sponsor ask for the same documents before each visit. With your site file online, your centre decides which monitor sees which study, and for how long. They review before they arrive, and visit time goes to the work that matters. See how research centres are moving their site files off paper.

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Ambulantisierung in der Urologie: Mehr Möglichkeiten durch Lasertechnologie Die Ambulantisierung verändert die urologische Versorgung. Gefragt sind Behandlungsmethoden, die medizinische Qualität, Patientenschonung und wirtschaftliche Effizienz miteinander verbinden. Moderne minimalinvasive Laserverfahren können dazu einen wichtigen Beitrag leisten: • Schonende, minimalinvasive Eingriffe • Kürzere Aufenthaltszeiten und schnellere Rekonvaleszenz • Neue Möglichkeiten für ambulante Behandlungspfade • Entlastung stationärer Versorgungsstrukturen TULA®: Die transurethrale Laserablation ermöglicht bei ausgewählten Patienten mit nicht-muskelinvasiven Blasentumoren eine ambulante Behandlung mittels flexibler Zystoskopie ohne Allgemeinanästhesie – gegebenenfalls in einem einzigen „See-and-Treat“-Termin. LEONARDO® Duster: Die Thulium-Faserlaser-Plattform (TFL) unterstützt effizientes Stone Dusting in der modernen Endourologie. Im Rahmen der Hybrid-DRGs entstehen neue Möglichkeiten, medizinische Qualität und wirtschaftliche Anforderungen besser miteinander zu verbinden – vorausgesetzt, die jeweiligen Anforderungen an Verweildauer, Kodierung und klinische Kriterien sind erfüllt. Erfahren Sie, wie biolitec® die ambulante Urologie mit innovativen Lasertechnologien unterstützt. #Ambulantisierung #Laserurologie #HybridDRG #Urologie #Krankenhausreform #biolitec

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