Wish you all a very happy Eid #ASCPharma #2024
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Join Navdip Sahota's session at #PharmacyU Vancouver on Saturday, November 2nd and learn how to master quick and efficient conversations to improve care for people living with T2D. More about the session here: ➡️ https://ow.ly/5b8250TqWij #pharmacy
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Another informative webinar from PDA Canada Chapter. Learn about Annex 1 implementation from Donald Singer. Details below.
🔔 NEW DATE🔔 Join us on Tuesday, March 5th at 12 PM EST for a webinar and live Q&A session on Annex 1. 📆 Please note the new date for this webinar is now Tuesday March 5th. Registration link: https://lnkd.in/eGJT9CHj ⏩ All attendees will receive an Attendance Certificate. Hear from Donald Singer, one of PDA - Parenteral Drug Association's experts on the EU’s Annex 1 revision, who will provide the audience with valuable feedback from industry and what has been heard from inspectors to date, following the EU implementation deadline, particularly from the standpoint of Contamination Control Strategy. The concepts learned from Don’s presentation will benefit Canadian stakeholders as the Health Canada Annex 1 implementation deadline approaches. Don will cover the purpose for the Annex 1 update, scope, principles, regulatory expectations, lessons learned including examples, and what is coming next. (French translation below. The event will be in English.) Donald Singer, l’un des experts de PDA Global sur la révision de l’annexe 1 de l’Union Européenne, présentera des informations importantes en ce qui concerne les attentes réglementaires à la suite de l’implantation européenne, et en particulier sur la stratégie de contrôle de la contamination. Les concepts tirés de la présentation de Don aideront les intervenants canadiens à extraire les informations importantes, et ce, en fonction de la période de mise en œuvre des lignes directrices de Santé Canada qui arrive à grand pas. Don couvrira l’objectif de la mise à jour de l’annexe 1, la portée, les principes, les attentes réglementaires, les leçons apprises, y compris des exemples, et de ce qui s’en vient. Sponsorship link: https://lnkd.in/eFth-xna ✨Thank you to our Gold Sponsors ✨ Lesirg Consultants ValGenesis CGI AtkinsRéalis ✨Thank you to our Silver Sponsor ✨ APS Compliance Consultants Inc. #pharmaceuticals #biopharma #PDACanada #GMP #CCS #Annex1 #regulatoryaffairs #lifesciences #sciencesdelavie Ecolab
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DTx in the USA – what are the requirements? 🌎🤔 Have you manufactured a #DTx and want to market it in the #USA? It’s possible. Although the process seems complex, we’ll give you some tips about where to begin. You should know that the body responsible for DTx certification in the United States is the #FDA (U.S. Food and Drug Agency). They provide society with information on whether or not a particular product is safe to use. How about the USA requirements for DTx? Swipe right to get familiar with them ➡️ It’s not the end of the story, of course, so we’ll give you more tips in our next posts. In the meantime, read more about DTx in the USA in our latest article ➡️ https://bit.ly/41Sk4Jc #digitaltherapeutics #digitalhealth #UShealth #medicalsoftware #softwaredevelopment
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Did you know we’re celebrating a special milestone this year? PhamaChoice Canada is celebrating 25 years, and over that time, we’ve accomplished some pretty spectacular things. However, we couldn’t have done it without the dedicated front store and pharmacy teams at each and every location across the country. This celebration goes beyond us. It also belongs to your communities! Tag your Pharmacy24 location in the comments below, and join us in celebrating! https://lnkd.in/dNVFsMA #PharmaChoice #Pharmacy #PharmaChoiceCanada #PharmacistsCare #CommunityPharmacy #YourPharmacy #PCH #PCC #LoveMyPharmacy #LocalPharmacy #Pharmacy24
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🔎 GS1 standards are essential for global harmonization in investigational product identification, benefiting patients, investigational centers, study sponsors, and their partners. At Creapharm, a Myonex company, traceability has always been a priority. As early adopters of 2D barcode traceability systems, we’ve consistently worked to enhance the safety and efficiency of clinical trials. We recently contributed to the GS1 Healthcare standardization workstream for clinical trial traceability, collaborating with companies like Pfizer and Sanofi, who chaired the working group. We’re thrilled to share this GS1 Healthcare success story, showcasing how Creapharm, now a part of Myonex, is transforming the clinical trial supply chain. #GS1HealthcareCaseStudies #GS1Healthcare #PatientSafety #GS1StandardsInClinicalTrials #Traceability #ClinicalTrials #Innovation
📢 We are very happy to share a new GS1 Healthcare’s success #story on how Creapharm, a Myonex company is transforming the clinical trial supply chain by using #GS1 #standards. This innovative approach is setting new benchmarks in drug #identification and #traceability, driving enhanced #safety and unmatched #efficiency across the industry. 💡 Read the full story now 👉 https://bit.ly/473ovU5 #GS1HealthcareCaseStudies #GS1Healthcare #PatientSafety #GS1StandardsInClinicalTrials __ GS1 France
New GS1 Healthcare’s success story on transforming the clinical trial supply chain.
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#LAC24 is kicked off in Dublin today🍀 Key high level panellists are on stage for the first panel debate form Muiris O’Connor from the Irish Dept. of Health, the European Patients Forum, and General Counsel from Fresenius Kabi and Sandoz. Discussions highlighted the need to improve the objectives of the European Commission #pharma reform: accessibility, availability, and affordability of medicines to ensure timely generic and biosimilar competition at IP expiry. This can be delivered by: - Regulatory modulation of incentives for innovation that keeps 11 years cap (data & market) while ensuring #Access to all member states - Harmonised #Bolar exemption across all MS - Incentivising innovation on #AMR through fairer and more effective alternatives to the transferable voucher Bird & Bird European Patients' Forum Fresenius Kabi Sandoz Department of Health - Ireland
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🚨 REGULATORY UPDATE 🚨 The FDA issued new guidance yesterday recognizing the June 2024 Circular of Information for the Use of Human Blood and Blood Components as an acceptable extension of container labeling. This update supersedes the December 2021 guidance and allows immediate implementation of the new Circular. Developed by the AABB Circular of Information Task Force, the updated Circular reflects critical updates in transfusion medicine, such as: • Identifying signs of transfusion-associated circulatory overload (TACO). • New details on leukocyte-reduced red blood cells collection. • Drug interactions impacting platelet function in whole blood. For more details and to access AABB’s user guide, visit our Circular of Information page. https://bit.ly/4eBU89R #FDA #TransfusionMedicine #BloodSafety #BloodBanking
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For those interested, the Live Broadcast of today's FDA ODAC meeting where #Carvykti and #Abecma will be discussed can be seen with the link below.
March 15, 2024 Meeting of the Oncologic Drugs Advisory Committee (ODAC)
https://www.youtube.com/
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Scientist | D.Phil (Oxon) | Strategy Consultant | Digital Health | Pharma Expert | Market Access/Pricing & Reimbursement/Health Economics/Outcomes Research (Pharma/Healthcare)
Great to see Canada taking steps towards creating a more sustainable and effective drug system for the future with the establishment of the Canadian Drug Agency (CDA) and an investment of $89.5 million! ➡ The government will collaborate with CADTH and provinces and territories to develop the CDA, building on CADTH's existing capabilities. The CDA aims to enhance Canada's drug system by addressing challenges such as high drug costs and inconsistent access. It will streamline processes, improve data collection for informed decision-making, and promote collaboration among provinces and territories to strengthen their bargaining power with pharmaceutical companies. ➡ This initiative complements the government's ongoing efforts to develop a national pharmacare program, known as the Improving Affordable Access to Prescription Drugs initiative, as well as support the National Strategy for Drugs for Rare Diseases with an investment of up to $1.5 billion over three years. #pharma #healthcare #canada #marketaccess #sustainability #genetherapy #cadth #CanadianDrugAgency #policy #drugdevelopment #affordability #healthtechnologyassessment #hta #BetterAccessToMedications #SustainableDrugSystem #dataanalytics
Check out the latest update at https://lnkd.in/eMZR3N-f The Canadian Agency for Drugs and Technologies in Health (CADTH) has announced that it will become the Canadian Drug Agency (CDA). This announcement was made by the Government of Canada on December 18, 2023, as part of a larger initiative aimed at enhancing the country's drug system and improving the health outcomes of Canadians, helping make Canada's drug system more sustainable and better prepared for the future. The CDA will be created by leveraging CADTH's existing capabilities in the pharmaceutical sector, and in collaboration with provinces and territories, as well as patients, clinicians, Indigenous leaders, and industry. The Government of Canada will invest $89.5 million over five years to establish the CDA, in addition to the current annual federal funding of $34.2 million to support CADTH. The CDA will retain CADTH's existing mandate and functions, including health technology assessment and post-market safety and effectiveness. Additionally, the CDA will expand to include new work streams, which include: ✴ Improving appropriate medication prescribing and usage for better patient health and system sustainability; ✴ Expanding nationwide drug and treatment data collection and access, including real-world evidence, to better support patients, inform healthcare decisions, and enable robust system data analytics; ✴ Reducing duplication and lack of coordination in the drug system to reduce inefficiencies and pressures. The establishment of the CDA will help address the challenges faced by the Canadian pharmaceutical system, including high drug costs and inconsistencies in access and coverage. Through streamlining processes, improving data collection, and promoting collaboration among provinces and territories, the CDA will expedite the availability of innovative medicines and strengthen Canada's bargaining power with pharmaceutical companies, ultimately leading to more affordable medications for Canadians. #pharma #healthcare #canada #marketaccess #sustainability #genetherapy #cadth #CanadianDrugAgency #policy #drugdevelopment #affordability #healthtechnologyassessment #hta #BetterAccessToMedications #SustainableDrugSystem https://lnkd.in/eMZR3N-f
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No one likes to make mistakes. But they happen. And isn't it always preferable to learn from others' than make the same ones yourself? Join Barry Moore, Head of RTSM at GSK at IRT next month, as he presents "Scary Bedtime Stories & RTSM Nightmares", to gain real world insights into RTSM failures, how to avoid common pitfalls and ensure best practice. Case Studies of RTSM Failures: Explore real-world examples of studies where poor RTSM practices led to significant issues, such as supply shortages, randomization errors, or unblinded data, highlighting the impact on study integrity, timelines, and patient safety. Identifying and Avoiding Common Pitfalls: Discuss the key lessons learned from these failures to ensure the integrity throughout the trial. Best Practices for Successful RTSM Implementation: Provide actionable strategies for mitigating risks in RTSM, such as implementing regular system audits, enhancing communication between study teams and vendors, and adopting adaptive supply strategies to ensure trial success. 👉 Register now: https://lnkd.in/e6hhqcKt 📑 Download the agenda to learn more: https://lnkd.in/eSntkB3T #IRT2024 #IRT #RTSM #ClinicalOperations #ClinicalSupply #ClinicalData #ClinicalResearch #ClinicalTrials #Clinical #Pharma #Biotech
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