Validation is broken and everyone knows it. We spend millions proving systems “work as intended,” yet we can’t even agree on what intended means. We generate mountains of documents, sign them in triplicate, and call it progress, but often, it’s just paper compliance. Validation was never supposed to be a paper pushing exercise. It was meant to prove trust, consistency, and patient safety. Maybe it’s time we stop validating for checking boxes and start validating for patient safety. Read the full article on the f2i partners website under industry insights. #Validation #GMP #Quality #Pharma #Innovation #F2iPartners
Validation: From Paper Compliance to Patient Safety
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Regulatory clarity isn’t just about understanding the rules — it’s about knowing how to apply them. This month’s 2025 AMDM IVD Focus Fall Meeting offered valuable discussion on where diagnostic regulation is headed — from FDA’s forthcoming QMSR and U.S. legislative priorities to global changes under the IVDR and Health Canada frameworks. In our latest blog 👉 https://lnkd.in/eyfpzFE4, Karin A. Hughes, Ph.D. shares key insights for diagnostic and device manufacturers preparing for 2026 and beyond — including practical ways to strengthen quality systems, align with global expectations, and stay ahead of regulatory change. At Beaufort, we help innovators turn regulatory shifts into market momentum — empowering our clients to advance diagnostic technologies and make a measurable impact. #Diagnostics #IVD #RegulatoryStrategy #FDA #MedTech
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📌 𝐓𝐡𝐞 𝐁𝐫𝐢𝐧𝐠 𝐘𝐨𝐮𝐫 𝐎𝐰𝐧 𝐓𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐲 (𝐁𝐘𝐎𝐓) 𝐢𝐧𝐢𝐭𝐢𝐚𝐭𝐢𝐯𝐞 𝐬𝐭𝐚𝐫𝐭𝐬 𝐬𝐢𝐦𝐩𝐥𝐞: 𝐞𝐂𝐨𝐧𝐬𝐞𝐧𝐭. -Sites bring their own validated eConsent solutions -Sponsors maintain oversight and compliance -Patients enjoy a smoother, more familiar process And it’s already addressing one of the industry’s biggest risks: FDA inspection findings related to informed consent. BYOT is how we fix it. 📖 See how the BYOT Playbook works: https://lnkd.in/gJSFPbK9 #BYOT #eConsent #TrialInnovation #ClinicalResearch
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Risk-Based Monitoring (RBM) in Clinical Trials RBM is transforming how we ensure patient safety and data quality. By focusing on critical data, key risks, and adaptive monitoring, trials become more efficient, cost-effective, and reliable. 🔹 Identify Risks 🔹 Assess Impact 🔹 Mitigate Issues 🔹 Continuous Monitoring Smarter monitoring → Safer trials → Better outcomes. #ClinicalTrials #RiskManagement #RBM #Pharma #DataIntegrity #PatientSafety #ccra
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📌 𝐓𝐡𝐞 𝐁𝐫𝐢𝐧𝐠 𝐘𝐨𝐮𝐫 𝐎𝐰𝐧 𝐓𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐲 (𝐁𝐘𝐎𝐓) 𝐢𝐧𝐢𝐭𝐢𝐚𝐭𝐢𝐯𝐞 𝐬𝐭𝐚𝐫𝐭𝐬 𝐬𝐢𝐦𝐩𝐥𝐞: 𝐞𝐂𝐨𝐧𝐬𝐞𝐧𝐭. -Sites bring their own validated eConsent solutions -Sponsors maintain oversight and compliance -Patients enjoy a smoother, more familiar process And it’s already addressing one of the industry’s biggest risks: FDA inspection findings related to informed consent. BYOT is how we fix it. 📖 See how the BYOT Playbook works: https://lnkd.in/exe-UKE6 #BYOT #eConsent #TrialInnovation #ClinicalResearch
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Risk-Based Monitoring (RBM) in Clinical Trials RBM is transforming how we ensure patient safety and data quality. By focusing on critical data, key risks, and adaptive monitoring, trials become more efficient, cost-effective, and reliable. 🔹 Identify Risks 🔹 Assess Impact 🔹 Mitigate Issues 🔹 Continuous Monitoring Smarter monitoring → Safer trials → Better outcomes. #ClinicalTrials #RiskManagement #RBM #Pharma #DataIntegrity #PatientSafety
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Legacy diagnostics meet new regulation. One of the biggest questions at IBMS 2025 was: what happens to existing products under IVDR? The answer lies in balance — maintaining continuity while meeting every new compliance demand. At BaxMed, that means close collaboration with notified bodies, strengthened technical files, and proactive communication across our supply chain. We’re reviewing all updates against the latest IVDR “significant change” guidance and MHRA registration requirements — ensuring every refinement strengthens reliability without disrupting supply. Discussions at IBMS 2025 echoed a common concern: “How do we ensure continuity without compromising compliance?” Behind the scenes, validation reviews, documentation upgrades, and performance evaluations are already underway — all to keep essential diagnostics in clinicians’ hands without disruption. Because for us, innovation doesn’t stop at a regulation. It adapts, improves, and keeps people supported. 💡 #IVDR #MedicalDevices #Compliance #Diagnostics #BaxMed
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Patient Assistance Programs are under more pressure than ever — from regulators, auditors, and patients alike. In my work with manufacturers, I see the same four vulnerabilities surface repeatedly: 1️⃣ Fragile funding foundations 2️⃣ Default-mode design 3️⃣ Brand erosion risks 4️⃣ Innovation lag Each one can quietly weaken a program’s stability and credibility. Sustainable PAPs balance compliance, compassion, and control — built to protect both patients and the brand promise behind every therapy. In our latest blog, Mary Lynn Kelley, President of eMAX Health Patient Services, shares four common “watch-outs” that derail PAPs — and how manufacturers can design programs that are sustainable, compliant, and aligned with their brand strategy. Read more: https://lnkd.in/e3ZpzS_p #PatientAssistance #HealthcareInnovation #Compliance #MarketAccess #Pharmaceuticals #HealthTech #PatientAccess #eMAXHealthPatientServices
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Digital health in Germany runs on evidence. BfArM’s DiGA pathway aligns innovation with measurable clinical outcomes. DDReg supports digital health companies in meeting DiGA requirements through clear regulatory pathways, evidence-based documentation, and strong compliance alignment. Read more: https://lnkd.in/guFfYBVD #DDReg #DiGA #BfArM #DigitalHealth #RegulatoryAffairs #Health #Tech #Pharma #Germany #Europe #Blog
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📌 CDP and Policy 0070 | Expanded Scope ↪ Since May 2025, the scope of #CDP has been expanded with the implementation of Step 2 of the Policy 0070 resumption, including: · All new Initial Marketing Authorization Applications · Line extensions & major Type II clinical variations · Negative opinions and withdrawn applications · Excluding biosimilars, hybrids, and generics · Legacy procedures approved during the policy suspension are now handled “upon request”, with clinical data requests triggering CDP procedures. At ASPHALION, we help you navigate this evolving landscape with expertise and tailored solutions: ✅ Liaison with #healthauthorities ✅ Redaction & anonymization strategies ✅ Execution of anonymization/redaction with Quality Check ✅ Preparation of anonymization reports ✅ Justifications for Commercially Confidential Information ✅ Publishing & submission activities 💡 Simplify your CDP process, ensure #compliance, and save time. 📧 Contact us now! info@asphalion.com #RA #RegulatoryAffairs #WeAreAsphalion #WeCare #KnowledgeFromExperience #Asphalion25Years #Asphalion25thAnniversary #AsphalionQuarterCentury #Asphalion25YearsOfKnowledge https://bit.ly/4qq11Se
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🔗 Part 2 of the Syneos Health CMC Blog Series: From Paper to Precision In this second instalment of our series on the shift toward structured regulatory submissions, we explore the FDA’s PQ/CMC initiative, a foundational step in transforming how we manage and submit CMC data. 📌 If you missed Part 1, catch up here:https://lnkd.in/e-KM8gS3 📘 In this post: Why structured PQ/CMC data matters now more than ever How it supports regulatory agility, lifecycle management, and global harmonization What companies can do today to prepare for tomorrow’s expectations 💬 Stay tuned for Part 3, Next up in the series: HL7 FHIR in Focus. stephanie snow, Masuma Essaji, Allison Gillespie, Stuart Goodall, Deepti Jagga, Dr Vivek Tomar, Hao Liu. #RegulatoryAffairs #CMC #StructuredData #DigitalDossier #PharmaInnovation #RegulatoryTransformation #LinkedInBlogSeries
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