Canopy Life Sciences的动态

In the dynamic healthcare landscape, the FDA's latest guidance on the use of Real-World Data (RWD) is a must-have development. It underscores the indispensable role of Electronic Health Records (EHRs) and medical claims data in evaluating the effectiveness and safety of drug and biological products. Key takeaway: RWD sources such as EHRs and claims data are instrumental in deriving Real-World Evidence (RWE) to support new drug indications and post-approval study requirements. With a robust framework, these data sources can enhance our understanding of patient outcomes in real-world settings. The 21st Century Cures Act has made the use of Real-World Evidence (RWE) in regulatory submissions a requirement, underscoring the increasing significance of integrating real-world insights into the drug development process. This guidance provides a roadmap to ensure data reliability and relevance. It addresses the selection of data sources, validation of study variables, and the overall quality of the data during accrual and curation. Ensuring accurate and comprehensive capture of patient data is paramount. The guidance outlines methods for validating operational definitions of study variables and highlights the importance of understanding the implications of potential data misclassification. See link to FDA guidance doc in the comments below ?? #RealWorldData #HealthTech #PrecisionMedicine #Pharmaceuticals ?? Follow xCures Read our LinkedIn Newsletter:?https://lnkd.in/dnNJV2ti https://xcures.com/ ??

?Last chance to register! Join us tomorrow in this insightful webinar to explore the latest developments in the EU medical device vigilance landscape, with industry-renowned specialist Veronika Valdova. Learn how to seamlessly integrate medical devices into your pharma portfolio, gain practical strategies for navigating regulations, and establish robust management processes. ?? Tomorrow, 17 April. Choose the time that best suits you: ?? Session 1: 6am ET | 12pm CET ?? Session 2: 10am ET | 4pm CET ?? Session 3: 2pm ET | 8pm CET ?? Register here: https://lnkd.in/e9q4cqRa ?? Key topics include: ? Introduction to Medical Device Regulatory Requirements ? Addressing Practical Challenges ? Key Takeaways ? Q&A Session ?? This webinar is ideal for: ? MedTech company leaders in acquisition by pharma ? Pharma company leaders expanding their portfolio to include device products. For any questions about this webinar, or if you would like to request the recording, please write to: [email protected]. See you soon! #Pharmacovigilance #MedicalDevices #EURegulations #PharmaDevices #MedicalDeviceRegulation #PharmaPortfolio #Webinar #Qinecsa

?? https://www.docqc.com ?? Discover the Future of Clinical Trials! ?? Our innovative FSP solutions are here to revolutionize your research process. From protocol design to regulatory compliance, we offer a suite of services designed to streamline every stage of your clinical trial. Our expert team is committed to accelerating drug development, enhancing patient outcomes, and advancing medical science. Embrace a tailored approach with significant budget savings. Let's bring new therapies to market, together. Explore how we can support your journey to innovation. Visit our site now! ???? #ClinicalTrials #InnovationInHealth #FSPSolutions #DrugDevelopment #MedicalScience #PatientOutcomes #HealthcareTechnology #ClinicalResearch #ProtocolDesign #TrialOperations #DataManagement #RegulatoryCompliance #PharmaIndustry #Biotech #HealthTech #ResearchAndDevelopment #FutureOfHealthcare #ClinicalInnovation #TherapyAdvancement #PartnerInScience

?? https://www.docqc.com ?? Discover the Future of Clinical Trials! ?? Our innovative FSP solutions are here to revolutionize your research process. From protocol design to regulatory compliance, we offer a suite of services designed to streamline every stage of your clinical trial. Our expert team is committed to accelerating drug development, enhancing patient outcomes, and advancing medical science. Embrace a tailored approach with significant budget savings. Let's bring new therapies to market, together. Explore how we can support your journey to innovation. Visit our site now! ???? #ClinicalTrials #InnovationInHealth #FSPSolutions #DrugDevelopment #MedicalScience #PatientOutcomes #HealthcareTechnology #ClinicalResearch #ProtocolDesign #TrialOperations #DataManagement #RegulatoryCompliance #PharmaIndustry #Biotech #HealthTech #ResearchAndDevelopment #FutureOfHealthcare #ClinicalInnovation #TherapyAdvancement #PartnerInScience

This past week, I had the privilege of discussing the importance of medical information within the life sciences industry with a group of pharmacy students. One key aspect we touched on is how unsolicited medical inquiries are handled through Medical Information Request Forms (MIRF). ? What is a MIRF? A standardized form used by healthcare professionals to request specific information about a drug or device that may not be readily available in the prescribing information. It’s a crucial tool in facilitating accurate, unbiased medical communication. ? Purpose & Use MIRFs streamline the process of providing critical information to healthcare professionals, ensuring they have access to the most current and reliable data to inform patient care decisions. ? Technology & MIRFs Today, platforms supporting MIRFs have enhanced their efficiency, making it easier to submit, track, and manage requests. This ensures healthcare professionals receive timely responses while maintaining transparency in communication. MIRFs are more than just a form—they are essential for bridging the gap between the pharmaceutical industry and healthcare providers, ensuring that the right information reaches the right hands when it’s needed most. #LifeSciences #Pharma #Biotech —————— ?? Follow me here on LinkedIn for clear, concise insights into the life sciences. I post three times weekly! ?? Subscribe to my monthly newsletter for deeper dives into topics important to the medical information space.

Many medical affairs teams want to measure their impact but focusing too much on activities rather than outcomes. To drive real change, it’s essential to commit to outcomes that truly matter, like increasing awareness of unmet medical needs or presenting data that challenges current clinical practices. At Acceleration Point, our Accelerated Insights program is designed to help teams define, measure, and align their work toward achieving those impactful outcomes. Let us help you commit to medical impact! Learn more here: ?? https://lnkd.in/e5AvRCJ8? #MedicalAffairs #Insights #pharmainnovation #Pharma #Kwello

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The role of a pharmacist goes well beyond delivering prescriptions, and GalenusRx Founder, Co-CEO, and CSO Jacques Turgeon has worked hard to expand that understanding, from perception to policies. GalenusRx encourages our Precision Clinical Pharmacists to make the broadest use of their considerable skill set—talking to patients, doing clinical services, using their deep scientific knowledge. With the APPRAISE?, which Dr. Turgeon co-developed, they're also given the tools to make a bigger, broader difference in medication safety, for individual patients and for healthcare at large. Learn more about Dr. Turgeon and his many contributions here: https://lnkd.in/gWDC9ZXK #Pharmacist #Healthcare #HealthTech #MedTech #Pharma #PharmaceuticalIndustry

Enhance clinical trials with patient-centric engagement! Clear Point Health's customized engagement programs support informed consent and ongoing participation, ensuring smoother trials and faster product development. #PatientEngagement #Pharma https://bit.ly/3VG8U9u

VPs of Digital Health pharma companies want faster and cheaper clinical trials. But they shouldn't have to sift through an oversaturated market of unreliable solutions to get there. They want to know: 1. Is it real? → Does the tech (actually) work and work well? 2. What’s the regulatory status? → Does the check the boxes for FDA clearances and ISO certifications? 3. Is the end point of measurement validated? → Has the company demonstrated gold standard accuracy and performance? → What publications or endorsements are backing up the product? Our sensors check all the boxes. We share upfront that our sensors work. We are ISO 13485 certified with 6 FDA clearances, CE Marked, and ICO 13485 certified. We are backed by many peer-reviewed publications, and respected pharma companies have endorsed us. Almost half of the largest Pharma companies are already working with us. It's easy for pharma companies to choose Sibel Health because we've already proven we can help. ____ PS - Check us out at sibelhealth.com