Register today for our next CEU webinar on Tuesday, August 20 at 1 PM ET! Our own Chief Clinical Officer Mary Mihalyo is presenting "Federal Regulations Guiding Prescribing of Controlled Substances: What Hospices Need to Know," a mission-critical one hour webinar for nurses and social workers. Learn more and register at https://lnkd.in/etrgv6-r.
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FREE for FSHP members (only $10 for nonmembers) - How to Monitor Patient Safety with Technology - hosted by FSHP's #MedicationSafety Clinical Forum 1 hour of CE for #pharmacists and #pharmacytechnicians - June 26, 6-7 PM Details & registration 👉 fshp.org/ce-programs #patientsafety #technology
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Following a clinical protocol properly is essential — so Scripted helps you get it right, every single time. Our platform intelligently walks pharmacists through our clinical protocols step-by-step, and flags potential contraindications and issues for manual review so nothing slips through the cracks. Plus, extra clinical guidance and accredited CE courses are always a click away. Learn more about supercharging your practice with Scripted: https://buff.ly/3extkh9 #LetUsPrescribe #PharmacistsProvideCare
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🕕 It’s not too late to register for tomorrow’s complimentary #PMCF webinar. All registered attendees will receive the recorded session after the event, so be sure to register now! 👉https://lnkd.in/giKXMsZF Smridula Hariharan and Parvathi Nambiar will discuss the foundation of post-market clinical follow-up (PMCF) and offer best practices to ensure that devices continue to be safe and effective. Find further information on our blog: https://lnkd.in/gUVUCjVJ #medtech #medicaldevice #medicaldevices #medicaldeviceregulation #mdr #ivdr #webcast #clinical #clinicalevaluation #pms #pmcfsurveys #postmarketsurveillance #clinicaltrials #mdrcompliance #eumdr #euivdr #postmarketclinicalfollowup #regulatoryaffairs #regulatorycompliance
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Clinical Research Expert | Driving Quality Assurance & Regulatory Compliance | Clinical Research Specialist
🚨 Clinical Research Professionals: Stay Informed on FDA Updates! 🚨 The FDA is making significant strides in modernizing clinical research oversight by aligning more closely with the HHS Common Rule. Here’s what you need to know: 🔹 sIRB (Single Institutional Review Board): A proposed FDA rule could mandate the use of a single IRB for multi-site studies. This change is aimed at streamlining the review process, reducing delays, and eliminating redundant reviews, all while ensuring participant safety. 🔹 HRPP (Human Research Protection Program): Comprehensive oversight continues to be critical. HRPPs are designed to protect the rights and welfare of research participants, ensuring all research is conducted ethically. 🔹 Informed Consent Enhancements: The FDA is also proposing improvements to the informed consent process, making it easier for participants to understand their role in studies, potentially increasing engagement and diversity in clinical trials. These updates are part of the FDA’s broader effort to make clinical trials more efficient and participant-friendly while maintaining robust protections for human subjects. Stay tuned for more developments and consider how these changes might impact your research projects! #ClinicalResearch #FDA #sIRB #HRPP #InformedConsent #MedicalResearch #RegulatoryUpdates Learn more here: FDA Official Site Watch this webinar from #AdvarraIRB https://lnkd.in/gqwc3GJj
Preparing Your Action Plan for the FDA sIRB Mandate
info.advarra.com
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Which states are stepping up to join the Interstate Medical Licensure Compact in 2024? 🤔 Tell us your predictions below! #MedicalLicensing #BusinessSuccess #InnovateWithLicentiam #HealthcareSimplified #CareerAdvice #RegulatoryGuidance #telemedicine #HealthcareCompliance #YourLicensingAlly #TeamLicentiam #LicensingSpecialist #ProfessionalDevelopment #ComplianceFirst #Telemedicine
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Today, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health Center (CDRH) is releasing two medical device reports on safety and innovation – the two pillars of CDRH’s work to assure that patients in the U.S. have access to high-quality safe and effective medical devices. The “CDRH 2024 Safety Report” and “CDRH 2024 Innovation Report” provide summaries of CDRH’s accomplishments and look ahead to future initiatives. Learn more: https://lnkd.in/eVgFDsg6
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What an inspiring plenary session on misinformation by Dr. Geeta Nayyar, MD, MBA at the 2024 Medical Affairs Professional Society (MAPS)!!! Jennifer Riggins Leena Jindia #misinformation #MAPSPR24 #medicalaffairs #medicalinformation #phactMI #patients
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Nail Your Clinical Trial Protocol! ✍️ A solid protocol is key to trial success—guiding everything from study design to patient safety. Get it right for accurate results and smooth approvals. Want to ace yours? Here are the tips you need! 🌍🔬 https://lnkd.in/gy2KpQcc #ClinicalTrials #ProtocolWriting #PharmaResearch #GCP
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Stay on top of the clinical trial regulations and the opportunities it presents for your company's future endeavors in the EU market. The EU-CTR, which came into effect on January 31, 2022, aims to simplify and harmonize clinical trials in the EU, replacing the EU Clinical Trial Directive (EU-CTD). This article highlights the shortcomings of the EU-CTD and emphasizes the binding nature of the EU-CTR on all EU member states. It also mentions the implementation of detailed arrangements for good clinical practice inspection procedures.
A Look Back as the EU Clinical Trial Regulation Moves Forward | PPD Inc
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Webinar Tomorrow (3/1): 'FDA's Rare Disease Day 2024' The FDA will host this virtual public meeting in global observance of Rare Disease Week. This year’s Rare Disease Day is dedicated to patients and #healthcare professionals. Discussion topics will include: - The legal framework for approving studies and #medical products at the #FDA - What the FDA does during review processes to approve medical products - Decentralized #clinicaltrials and digital #health technologies - Where to find important information and documents related to clinical trials - Information that can be obtained from medical product labels - #Legal and ethical requirements for consent forms in clinical trials - FDA initiatives to advance medical product #development for rare diseases - Ways for patients to engage with the FDA Learn more and register: https://lnkd.in/eazYFiKn #rarediseaseday2024 #clinicalresearch #technology #healthcare
Public meeting: FDA Rare Disease Day 2024
fda.gov
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