CaptaiNext MED’s Post

👉 Ensuring every dose delivers hope 🌡️💊 Dive into the world of pharma cold chain monitoring where precision meets care, safeguarding the journey from lab to life. ❗️❗️Follow us for more information in the field of logistics and monitoring 🌐 ecohellas.gr 📧 ecogrnet@otenet.gr ⠀ ⠀ #SmartTechnology #ReliableMonitoring #ClimateMonitoring #DataDrivenDecisions #SmartSensors #EnvironmentalSustainability #RealTimeMonitoring #DataAnalytics #PharmaCare #ColdChainCommitment #HealthSafety

Did you know? Successful FDA approval processes often hinge on early, effective collaboration. Better coordination and communication can streamline interactions between regulatory bodies and industry professionals. It's more than just teamwork—it's a formula for success! Learn more about how Stat One can help below. #FDA #healthcarecollaboration #approval #biotech #medtech #FDAapproval #FDAapproved https://lnkd.in/eWCFQc6z

The Medicines and Healthcare products Regulatory Agency is inviting members of the public, including the #patients, #medicaldevice researchers, developers, #manufacturers and #suppliers, #clinicians, other #healthcareprofessionals to provide their views on the introduction of #commonspecifications requirements to the regulatory framework before #IVD devices can be placed on the #GreatBritain market. Read more: https://lnkd.in/dgtCzsif This consultation closes at 11:59pm on 14 June 2024 #medtech #biotech #medtechnews #biotechnews #invitrodiagnostics #companiondiagnostics #diagnostics

ePI (electronic Product Information) FHIR (Fast Healthcare Interoperability Resources) labeling is the future of pharma compliance. Discover how Freyr's end-to-end solutions help streamline your labeling process, meet global Regulatory standards, and enhance patient safety. https://lnkd.in/dkKFyV56 Swipe left to learn more! #ePIFHIR #RegulatoryLabeling #PatientSafety #PharmaReg #LabelingProcess #FreyrSolutions

Enbio : Global Standards, Local Trust Enbio is backed by a global network of safety certifications, ensuring the highest standards of quality and reliability. TÜV NORD: A leading German certification body, recognized worldwide. MDSAP: Medical Device Single Audit Program, streamlining regulatory processes. GKE: German Medical Device Certification, a rigorous standard. US FDA: United States Food and Drug Administration approval, ensuring safety and efficacy. SAL: Sterility Assurance Level, guaranteeing a high level of sterility. Now, CDSCO-Approved: Meeting India's stringent regulatory requirements. Trust Enbio Pro for sterilization solutions that are trusted worldwide. #EnbioPro #Sterilization #CDSCOApproved #GlobalStandards #SafetyFirst #MedicalDevices #Dental #Laboratory #Innovation #SwissDesign #India

𝐈𝐦𝐩𝐨𝐫𝐭𝐚𝐧𝐭 𝐮𝐩𝐝𝐚𝐭𝐞! FDA has just released the final guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations 𝐏𝐫𝐞𝐬𝐬 𝐭𝐡𝐞 𝐟𝐨𝐥𝐥𝐨𝐰𝐢𝐧𝐠 𝐥𝐢𝐧𝐤 𝐟𝐨𝐫 𝐭𝐡𝐞 𝐟𝐮𝐥𝐥 𝐠𝐮𝐢𝐝𝐚𝐧𝐜𝐞. https://lnkd.in/gUs56N6W 𝐀𝐫𝐞 𝐲𝐨𝐮 𝐬𝐭𝐫𝐮𝐠𝐠𝐥𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐤𝐞𝐞𝐩𝐢𝐧𝐠 𝐩𝐚𝐜𝐞? We are here to help you align with the latest guidelines. 𝐂𝐨𝐧𝐭𝐚𝐜𝐭 𝐮𝐬 𝐡𝐞𝐫𝐞: https://lnkd.in/d_8jYVxw hashtag #pharma hashtag #Biotech hashtag #Biopharma hashtag #regulatoryaffairs hashtag #regulatorycomplience

FDA guidance this week - much more on their web site but those which may be of particular note to the GMP world released this week are: 7/25/2024 - Providing Over-the-Counter Monograph Submissions in Electronic Format 7/25/2024 - Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products: Guidance for Industry 7/24/2024 - Container Closure System and Component Changes: Glass Vials and Stoppers 7/23/2024 - Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers Happy reading and gap assessing!

#Friday_Evnia_Treats The EU-MDR creates significant regulatory challenges for drug-device combination product manufacturers since these products may be regulated either as #medicinalproducts or #medica devices, depending on their primary mode of action. Understanding how to navigate regulatory challenges can have a significant impact on both the strategic planning of a manufacturer/developer and patient safety. In particular, the approval process for manufacturers of integral combination products now requires an opinion from a notified body (NBOp) affirming the conformity of the device part to the applicable General Safety and Performance Requirements (Art. 117). This opinion must be included in the Marketing Authorisation Application submission and is critical to the approval pathway. Article 117 applies to a wide range of products such as #autoinjectors, #inhalers, pre-filled #nebulisers, pre-filled #pens, pre-filled #syringes and #transdermal #patches. Evnia has summarised the types of #combinationproducts and their respective regulatory pathways in a short video. Contact us if you need assistance with your regulatory/clinical journey! #medtech #medtechnews #pharma #pharmanews #technicaldocumentation #notifiedbodies #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #cemark #cemarking #EVNIA_AR #Evnia_UKPR #regulatoryaffairs

I am proud to share this blog that was collaboratively developed by the NovaSterilis and iFyber teams on the topic of sterilization validation - https://bit.ly/3TQ8QD0. Also, a shoutout to former team member Devin Zysling Craven whose work and imagery while at iFyber makes this topic easier to process and understand. For those of you bringing new medical products to market, I hope you find this informative as you think about your sterilization strategies. #sterilization #validation #supercritical #regulatory

🌟 Webinar Alert: Navigating Regulatory Roadmaps for Combination Products 🌟 Are you developing a combination of medical devices and medicinal products and navigating the complex regulatory landscape? Join the expert-led webinar of our partner LifetecZONe. 𝐊𝐞𝐲 𝐓𝐨𝐩𝐢𝐜𝐬: ▶️ Understanding the regulatory requirements for medical devices and medicinal products in the EU. ▶️ Navigating the differences between CE marking and marketing authorization. ▶️ Determining applicable regulations for your product and required technical documentation. ▶️ Exploring FDA regulations for combination products in the U.S. 𝐖𝐞𝐛𝐢𝐧𝐚𝐫 𝐀𝐥𝐞𝐫𝐭: 🗓️ Date: September 9th ⏰ Time: 13:00-15:00 📍 Location: Online This training is offered by Holland Innovative, Interdos and @novioneon CRO GmbH. Whether you aim to access the EU or U.S. markets, this webinar will equip you with the knowledge to start building your regulatory file confidently. 🔗 register now: https://lnkd.in/dMZcesF2 This event is part of the BioMan4R2 project within the European SMP COSME program, supporting SMEs in the biological products and medical technology sectors to boost resilience and competitiveness. #CombinationProducts #RegulatoryCompliance #BioMan4R2 #MedicalDevices #MedicinalProducts #Webinar #RegmedXB