Our session on “A Psychedelic Shift: Assessing the Potential for Nonmedical Use in a Changing Regulatory Landscape” is starting in the next few days and we want to make sure you can attend! Register now if you want to learn: ✔️ The evolution of terminology in psychedelics ✔️ How to assess non-medical use ✔️ Tips for engaging health authorities ✔️ Challenges associated with assessing non-medical use in psychedelics research Share this post with your network and register here: https://hubs.li/Q02CBWqm0 #OneMMS #Psychedelics #DrugDevelopment #Regulatory #Pharmaceuticals
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Surprising fact: 8% of branded drugs in the US account for a whopping 84% of the total cost. 🤯 The issue? Patents. When a brand holds the patent, they’re the sole producer until it expires, and this applies to many widely used medications. Is this a fair system? What’s the solution, in your opinion? Let’s have an open discussion in the comments - your insights matter! 💬 👇 #Pharmacy #Pharmaceuticals #Medication #Healthcare #DrugCosts #MedicationAccess #PharmaIndustry #Prescriptions #HealthTech #PatientCare #Rx #MedicationSafety #DrugDevelopment #HealthInsurance #Pharmacists #DrugResearch #Medicare #FDA #MedicationManagement #HealthPolicy #DiRx
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ICH E6 R2 is a scientific guideline for good clinical practice (GCP). It was first published in 2002. The guideline sets an international standard for designing, conducting, recording, and reporting clinical trials that involve human subjects. . . . #healthcare #healthcareheroes #healthcareworkers #healthcarreservices #healthcareprofessionals #healthbudget #heathcarebudget #unionbudget #unionbudget2023 #pharmaceuticals #pharmacy #pharmasector #pharmasectornews #pharmabudget #healthiswealth #healthcare #MITCON #mitconbiopharma
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❗𝐍𝐞𝐰 𝐁𝐥𝐨𝐠 𝐏𝐨𝐬𝐭 ❗ https://lnkd.in/eGQymN8H As the medical device industry continues to grow, so do the accompanying safety regulations. Each medical device undergoes a standards assessment to ensure its safety. 𝐓𝐨𝐝𝐚𝐲𝐬 𝐏𝐨𝐬𝐭: 𝐔𝐧𝐥𝐨𝐜𝐤𝐢𝐧𝐠 𝐓𝐡𝐞 𝐈𝐦𝐩𝐨𝐫𝐭𝐚𝐧𝐜𝐞 𝐨𝐟 𝐓𝐡𝐞 𝐒𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐬 𝐀𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭 In this blog, we will explore the importance of standards assessment in the medical device industry, describe the assessment process, and introduce MEDVACON, a consulting company that can assist businesses in this essential endeavor. Stay tuned for part 2 of Standards Assessments coming next week! Drop us a follow to be notified when its released! #medicaldevice #meddevice #standards #manufacturing #medicaldevicemanufacturing #medicaldeviceindustry #pharamceuticals #pharma #pharmceuticalmanufacturing #biotechnology #biopharmaceuticals
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Happy Doctors' Day! Today, we honour and celebrate the incredible dedication, compassion, and hard work of our doctors. Thank you for being our heroes in white coats. Let's take a moment to appreciate and thank the doctors who make a difference in our lives every day. #ThankYouDoctors #HealthcareHeroes #MedicalExcellence #DoctorsDay2024 #medicine #medical #pharmaceuticals #pharma #clinical #clinicaltrials #JSTL #Jeevanscientifictechnologylimited #Jeevanscientific #clinicalresearch
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https://clinfinite.com/ ✅At Clinfinite Solutions, we deeply value and understand the intricate regulatory framework guiding drug approval. ✅Together, let's synergize our expertise to maneuver through the clinical development journey, delivering groundbreaking and accessible medications to every patient. ✅ With unwavering competence and empathy, we strive to foster trust and admiration among our worldwide clientele, team members, and the individuals relying on our innovations. ✅ As a clinical research organization, our mission is to harmonize knowledge and compassion, ensuring each step we take contributes to the betterment of healthcare globally. #ClinicalDevelopment #DrugApproval #HealthcareInnovation #PatientCare #ClinicalResearch #GlobalHealth #Pharmaceuticals #HealthcareAccessibility #TrustAndRespect #MedicalAdvancements
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⏰ The Nevada Spend & Sample Disclosure report deadline is approaching fast, set for March 1st. Are you ready? We're curious about your experience with preparing for this deadline. In the comments below, let's discuss: 1. How smooth was the process of gathering your samples data, spend data, and rep licensure data? 2. Was cleaning up the spend data a straightforward task? 3. How long did it take to gather the 2023 data from various stakeholders? Let's share insights and help each other navigate through this deadline efficiently. #NevadaDeadline #CompliancePreparation #PharmaIndustry #GMHealth #ComplianceMatters #TrustedPartner #Pharmaceuticals
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Be S.M.A.R.T. - Achieve More with Less Effort! Freyr Digital presents an all-in-one Regulatory Suite. Seamlessly manage document lifecycles (Freyr rDMS), track submissions (Freyr SUBMIT Track), and make hassle-free Submissions (Freyr SUBMIT PRO) – all in one place, all Health Authority compliant, updated, and cost-effective. Curious to know more about it? Find out more here: https://hubs.ly/Q0223qN10 #FreyrDigital #RegulatoryAffairs #Biotechnology #Pharmaceuticals #Lifesciences
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CEO, Board Member, Biotechnology Pharmaceutical Consultant, Speaker, Author, Governance, Risk Management, Audit & Compliance, Clinical Product Development, Public, Privately Held, Family-Owned
Update on: EU Medical Device Regulation (MDR) where manufacturers are expected to commit to postmarket clinical follow-up (PMCF). Real World Data Uses for EU Devices: 1) Submissions 2) Post-Market data on how device performs during actual clinical use (RWD & RWE) RWD sources include disease- or device-based registries and administrative data. Potential drawbacks: 1) RWD are likely to be observational 2) Data entry may lack detail 3) May not be long term 4) May be more focused on safety than effectiveness Real world data and evidence is here to stay as devices become more complex and there are more of them. Additionally with software components that need updating during the devices lifetime, RWD and RWE offer a way to continue to monitor performance in larger populations under true to life conditions. What are your thoughts on RWE and RWD? #biotechnology #pharmaceutical #compliance #riskmanagement
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#RegUpdatesWithRegDesk The Food and Drug Administration (FDA or Agency) has issued this draft guidance document to introduce submitters of De Novo requests to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) to the current resources and associated content developed and made publicly available to support De Novo electronic submissions to FDA. Get daily regulatory alerts sent straight to your inbox - stay informed effortlessly! Get Started: 👉 https://lnkd.in/d8yWnPkj #regdesk #holisticrims #rims #software #entrepreneurship #medtech #lifescience #healthcare #health #diagnostics #meddevice #regulations #pharmaceutical #pharmaceuticalindustry #ai #technology #future #innovation #medicaldevices #regulation #usa
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Free webinar 14MAY2024, 1-2 PM ET. "After several years of relatively little enforcement, FDA has recently been flexing its muscles in the promotion area. The Office of Prescription Drug Promotion (OPDP) in particular has issued several notable warning and untitled letters in the past year, representing an increased volume in enforcement and increased scrutiny of efficacy claims. This includes more rigorous assessment of information 'consistent with' FDA-required labeling (CFL) and enforcement of new expectations for presentation of quantitative efficacy information. Tune in to this overview session for an efficient rundown of what this means for drug, biological product, and device manufacturers in terms of key watchouts and practical approaches to risk mitigation." #FDA #Labeling #AdvertisingAndPromotion #OPDP #WarningLetter #UntitledLetter #NOV #Pharmaceuticals #Biologics #MedicalDevices https://lnkd.in/dRdbWjR2
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