MEX™, making mastitis management easy’s Post

✴ We are excited to announce our participation at this year's TOPRA Symposium.   🗓 From the 30th of September till the 2nd of October, MAIN5 will be exhibiting at the TOPRA Symposium 2024 in Rotterdam. This premier event, held in partnership with the Medicines Evaluation Board (MEB), is a cornerstone for regulatory professionals in the healthcare industry. Whether you're involved in human medicines, medical devices, IVDs, or veterinary medicines, your participation will provide invaluable insights into the evolving regulatory landscape.   🤝 We invite you to join us and explore the latest trends and innovations in regulatory affairs. Meet our experts Tore Bergsteiner, Katharina Mayer, Michiel Stam, Piotr Wierzchowski, and Marjeta Panjan Žalec, and discuss how MAIN5 can support your regulatory strategies with our tailor-made solutions.   📧 Let’s connect! Reach out via marjeta.zalec@main5.de to schedule a meeting with our experts.   Don't miss this opportunity to network with peers, engage with industry leaders, and advance your professional knowledge.   👋 We look forward to seeing you there!   #TOPRASymposium2024 #RegulatoryAffairs #Healthcare #Innovation #Regulatory 

Will we meet at our next public event? Here the list of upcoming events where we speak in Italy, Belgium, Switzerland (see link in the first comment) #dissemination #EUfunded #cerebralpalsy #AIInnovation #personalisedmedicine #staytuned #SINPIA #SIMFER #EUPPT #BeCPR

📢 Exciting News from #EPAA! 🐇💉 We're thrilled to announce a major milestone: the European Pharmacopoeia (Ph. Eur.) has officially removed the rabbit #pyrogen test (#RPT) from its standards! 🚫🐰 In June 2024, the Ph. Eur. Commission adopted 57 revised monographs and a new general chapter on #Pyrogenicity (5.1.13). This marks the end of the RPT era in ensuring the safety of injectable #medicines in Europe. This achievement is a testament to the exceptional collaboration between the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe experts and EPAA’s “Harmonisation of #3Rs in Biologicals” project team. Special thanks to the Joint EDQM-EPAA Workshop held in Brussels in February 2023, which played a crucial role in this success. 🌍🔬 ( https://lnkd.in/d-A7kym9 ) Key points: 🔹 RPT will no longer be required by Ph. Eur. from July 1, 2025. 🔹 Medicine developers will now use suitable in vitro tests, like the Monocyte-Activation Test, for pyrogenicity control. This is a significant win for #animalwelfare and a step forward in scientific #innovation. 🧬✨ For more details, read the full press release: https://lnkd.in/dkiWvPNp #EPAA #Pharmaceuticals #ScientificProgress

What will be the priorities of the candidate for EU Health Commissioner—and will he be approved or see his role diminished? Unusually, Commissioner-designate for Health and Animal Welfare Olivér Várhelyi faced not just a hearing with MEPs but also two rounds of written questions.   Várhelyi identified revision of the EU general pharmaceutical legislation, the Critical Medicines Act and European Biotech Act, and the revision of the medical devices legislation as the pillars of a thriving European life sciences industry. If appointed, he would seek to “reach a balanced compromise agreement on the revision of the pharmaceutical legislation. I commend this House for setting out already its position. I do hope that the Council will also be swift in developing its own.”   In his view, “Europe should be a dynamic centre for biotechnology.” The European Biotech Act would help to realise the potential of this industry, especially if it is combined with AI and data from the European Health Data Space. To boost the industry's competitiveness, Várhelyi would seek to bring businesses and European academic institutions together.   Proposing the Critical Medicines Act within 100 days of his appointment would be a high priority. This legislation is “a key initiative to enhance the availability and European manufacturing of medicines and boost the EU’s economic security in health, complementing the measures discussed in the revision of the pharmaceutical legislation. The #Critical #Medicines Act can also support innovative manufacturing technologies and can be a useful tool to create market incentives—for example, by joint procurements to address the market failures, including also in relation to orphan drugs and rare diseases or the lack of new antibiotics. These initiatives will help us not just to complete the European Health Union but also to lay the ground of a modernised, competitive and resilient #EU health ecosystem which will deliver for our citizens.”   In the war against antimicrobial resistance, Várhelyi would aim to create “a market for new and more effective antibiotics developed and manufactured in Europe.” He would ensure that the list of reserve antibiotics is kept up to date with cutting-edge science.   Preventive health would also be high on Várhelyi’s agenda. He noted the success of Europe’s Beating Cancer Plan and intends to pursue a similar strategy for #cardiometabolic diseases, including diabetes and obesity, with a focus on improving prevention, diagnosis and treatment—particularly for women. He believes the plan should “help us to develop and make available new and personalised ways of prevention and treatment for Europeans based on our work and within the European Health Data Space.”   Opposition to Várhelyi’s candidacy relates largely to his stance on women’s rights, competitiveness and animal welfare, his links to Hungarian Prime Minister Viktor Orbán and negative comments he has made about MEPs in the past. #healthcommissioner

For pyrogenicity control Monocytes -Activation Test will be used instead of Rabbit pyrogen test

🌟 I’m delighted to have presented three posters yesterday at the Royal Pharmaceutical Society summarising the roadmap of my recent research from 2020-2024. 📊 The first poster explored a #quantitative analysis of antibiotic trends from 2019 to 2020, covering 640 patient records and identifying prescribing patterns through the World Health Organization #AWaRe classification. 👩⚕️ The second poster highlighted #qualitative insights from healthcare workforce views on antibiotic prescribing during crises, showcasing perspectives across roles: Doctors (Awareness), Pharmacists (Concern), and Nurses (Challenge). 🌍 The final poster introduced a proposed practical tool aligned with the International Pharmaceutical Federation (FIP) Global Roadmap 2030: a sustainable antimicrobial stewardship framework with an innovative antibiotic dashboard. This tool is designed to strengthen sustainability, resilience, and emergency preparedness in antimicrobial stewardship. Looking forward to practice these findings and exited to continue this journey towards a sustainable and resilient antibiotic stewardship evident-based practices! 🌱 #AntimicrobialStewardship #AMR #HealthcareResilience #RPSConf24 University of Hertfordshire #WAAW24 #AntimicrobialResistance Prof Zoe Aslanpour Nikkie Umaru

🚀 Exciting News in Pyrogen Testing! 🚀 The European Pharmacopoeia (EP) has announced the new Chapter EP 5.1.13 Pyrogenicity, set to replace the rabbit pyrogen test (RPT). With the immediate implementation of Compendial MAT EP 2.6.30 and recombinant Factor C EP 2.6.32, the stage is set for more reliable and sustainable testing strategies. At CellMade, we are proud to lead the way in endotoxin and pyrogen detection with our state-of-the-art toolbox, tailored for non-routine projects. Our comprehensive approach covers everything from root cause investigations to alternative testing methods, method development, and product-specific validation. Our Pyrogen Testing Toolbox offers unparalleled precision, efficiency, and reliability. We've successfully employed the Monocyte Activation Test (MAT) for testing human albumin 20%, navigating the complex risks of both endotoxin and non-endotoxin pyrogenic contamination. Our toolbox also provides precision through tailor-made hold-time studies, meeting your unique requirements. One of our key highlights is EndoLISA® success, our preferred technique that revolutionizes endotoxin testing, particularly benefiting wound dressings made of natural materials like collagen. Choose CellMade for: ✅ Streamlined sample submission ✅ Automation for consistent results ✅ Versatility to meet diverse needs ✅ Fast turnaround time Ready to elevate your pyrogen testing experience? Contact us today and join the innovation journey with CellMade. Say farewell to traditional methods and embrace a future of advanced testing solutions. hashtag #PyrogenTesting #AdvancedTestingSolutions #InnovationJourney #LaboratoireCellMade https://lnkd.in/eUe3acms

🌟APUA webinars | Invitation to attend🌟 We are pleased to share details of two short webinars hosted by the Alliance for the Prudent Use of Antibiotics (APUA) happening next week. We are hosting two webinars to ensure we cover as many time zones as possible. The main aim of these webinars is to identify and prioritise the objectives of existing APUA members. But we also invite colleagues interested in joining APUA to attend. There will be a short introduction / overview of ISAC and APUA and a presentation from one of our Project Grant Awardees. The majority of the webinar will be devoted to group discussion so we can decide how we can best serve our members. To attend the webinars, please register using the links below (there are two registration links so if you want to join both webinars, please sign up to each one). Places are limited and existing members will receive priority. 18 September, 17.00 - 18.00 CET REGISTER⬇ https://lnkd.in/eeAhmfAC 19 September, 10.00 - 11.00 CET REGISTER⬇ https://lnkd.in/ed-zbePN #superbugs #healthcare #antibioticresistance #infectiousdisease #clinicalmicro #antibiotics #antimicrobialstewardship #antimicrobialresistance #antimicrobials #clinicalmicrobiology #fungalinfection #globalhealth #publichealth

🧬 Investigating Coronaviruses in Berlin’s Rat Population 🧬 A recent study in Berlin has shed light on the presence of coronaviruses in the city’s Norway rat population. Researchers tested 130 rats to determine whether SARS-CoV-2 or other coronaviruses were circulating among these urban rodents. Interestingly, while no evidence of widespread SARS-CoV-2 was found, one rat tested positive for antibodies to the Omicron variant, indicating a possible isolated spillover from humans. However, several rats were found to carry alphacoronaviruses, highlighting the need for continued monitoring of rodent populations. These findings underscore the importance of studying animals like rats, as they may play a role in the transmission and evolution of viruses with zoonotic potential. The study emphasizes the value of proactive surveillance in understanding virus dynamics in urban wildlife and informing public health strategies. https://lnkd.in/e6BeVrHw Key Insight: While SARS-CoV-2 does not appear to be circulating in Berlin’s rats, other coronaviruses are present, warranting ongoing research to mitigate future zoonotic risks. 🐀🔬 #PharmaManufacturing #BiotechSolutions #CDMOServices #ContractManufacturing #DrugDevelopment #PharmaceuticalInnovation #Biopharma #ClinicalDevelopment #BiotechManufacturing #HealthcareSolutions #LifeSciences #PharmaContracting #CDMOExperts #RegulatoryCompliance #PharmaOutsourcing #CDMOInnovation #DrugProduction #PharmaTech #BiotechPartnership #ContractResearch

🚨Update in Drug Development 🚨 The European Pharmacopoeia (Ph. Eur.) has officially removed the rabbit pyrogen test (RPT) from its monographs. This marks a significant step towards reducing animal testing in medical research. The RPT, used for decades to ensure the safety of parenteral medicines by measuring temperature changes in rabbits, will be replaced by more ethical and modern methods. This change aligns with the global shift towards the 3Rs principle: Replacement, Reduction, and Refinement of animal testing. Genoskin’s ex vivo platforms are designed to provide the most accurate alternative to testing in humans. Our comprehensive immune profiling capabilities present a promising path for replacing the rabbit pyrogen test (RPT). Learn more: https://lnkd.in/eN8q5mcg #drugdevelopment #rabbitpyrogentest #3Rs