🌟 The EMA Management Board has adopted revised transparency rules for the publication of information on clinical trials submitted in the clinical trial information system (CTIS). 🧪🔍 🔎 This latest update in transparency rules will apply after their technical implementation in CTIS, including the public portal, which is expected to be finalized in the second quarter of 2024. 📚 Stay tuned for more updates on this topic. If you have any questions, our team of experts is here to provide tailored advice. 🚀🔬 #ClinicalTrials #TransparencyMatters #ScienceCommunity #MedicalResearch Veronique Gelebart, Gaëlle Preiss, Jannette Mabelly Hernandez Olvera, Claire Menette, Abby Brehm, Nathan Escutnaire, Maria Thomas, Darius Vagrys
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It was a great pleasure to exchange ideas and share expertise in microbiome research and innovation with microbiome community in UK last week at the event of UK Microbiome One Health Conference. If you missed the opportunity to discuss your microbiome product development with our team, no worries, we will be hosting an "Ask the Experts" session" on 🗓 Sept 19th at 17:00 to answer your questions. Free registration here: https://lnkd.in/edFTFuEi Clara Desvignes, Olaperi Aghadiuno, Pauline Lestringant, Christelle Fasano, Tom Beach
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The FDA has introduced new draft: Platform Technology Designation Program for Drug Development Guidance for Industry, which are impacting drug, biologic, and medical device development, including mRNA platforms and gene therapy vectors. These changes offer opportunities to streamline development and regulatory pathways. We summarize the key elements of this guidance and some key strategies for navigating this draft guidance and how it can benefit your company's innovation efforts. 👉 Read the full blog post here: https://lnkd.in/evGj8PYq #LifeSciences #FDA #Regulatory #PlatformTechnologies #DrugDevelopment Victoria Quiroga, Nicole Cohen, Michael Day, Christelle Fasano
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This week we will be attending ESMO 2024 one of the key events in the global oncology community! 🎗️ This congress is a great opportunity to exchange insights on advancing cancer care. We look forward to connecting with industry leaders and discussing how we can help bridge the gap between cutting-edge therapies and the patients who need them most. If you’ll be at ESMO 2024, let’s connect and explore how we can work together to make a meaningful difference in oncology. https://lnkd.in/eWbbn24Q Olaperi Aghadiuno, Tom Beach, Christelle Fasano #ESMO2024 #Oncology #CancerCare #Innovation #PatientCentric #LifeSciences #Collaboration
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📢 This week, we had the privilege of chairing a thought-provoking discussion on the "Practical Aspects of Applications of In Silico Technology in Health Tech Product Development" at Avicenna Day organized by Avicenna Alliance at VPHi 2024 Conference with industry experts and innovators in this field: - Roger Assaker from MDsim - Dr. Simon J. Sonntag from Virtonomy.io - Nishant Ravikumar from adsilico Limited - Erica Beaucage-Gauvreau from isihealth It was an incredible opportunity to engage with them and the audience. Our panel delved deep into the evolving role of in silico methods, showcasing how computational models are revolutionizing healthtech product development. We focused on the practical implications, from early-stage R&D to clinical trials, and explored the crucial regulatory framework needed to foster widespread adoption. Advancing the regulation of in silico technology is essential to unlocking its full potential in healthtech development. We are actively contributing to this dialogue by advocating for clearer regulatory pathways, supporting validation frameworks, and emphasizing the importance of collaboration between industry and regulators. This is a time of innovation, and we are excited to be part of it. 🚀 #VPHi2024 #InSilico #HealthTech #DigitalHealth #DrugDevelopment #Regulation #Innovation Shiny Martis Ph.D, Cecile Rousseau, PhD, Emmanuelle Voisin, PhD, Christelle Fasano
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Our next "Ask the Experts" session will talk about microbiome product development in the EU and the US. If you have any questions, feel free to register yourself to this interactive session much appreciated by our community. 🗓 Date & Time: Sept. 19th, 17:00 CET 📢 Format: Online Q&A session 👉 Free registration: https://lnkd.in/edFTFuEi Pauline Lestringant, Ph.D. and Clara Desvignes will answer your questions live! #microbiome #regulatory #webinar
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We are attending UK Microbiome One Health Conference in Liverpool next week! Our experts specialized in microbiome product development Olaperi Aghadiuno (former MHRA) and Clara Desvignes would be glad to discuss with you about your microbiome product development plan. With other key industry KOLs, we are happy to speak at the workshop of "Addressing key challenges in #microbiome innovation" on Sept. 11th. 👉 Feel free to book a meeting with Peri and/or Clara: https://lnkd.in/eWbbn24Q
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If you are life science innovator attending ISPE next week, come and connect with our team of MedEngine at this key industry event! Tero Ylisaukko-oja, Heidi Loponen and Juha Mehtälä will be happy to meet you.
🇩🇪 The 2024 ISPE Annual Meeting is coming next week, and we’re heading to Berlin! MedEngine’s Tero Ylisaukko-oja, Heidi Loponen, and Juha Mehtälä are excited to connect with you. Don’t forget to book a one-to-one meeting at info@medengine.fi if you’re interested in hearing more about our services. Our Lead Data Scientist Juha Mehtälä is also taking part in an ISPE poster session on Monday the 26th at noon. See you there! #MedEngine #TheValueIsInTheLinks #RWE #ISPE2024 #Pharmacoepidemiology #HealthcareInnovation
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Microbiome science has grown over the past years with high potential to provide innovative, efficient, and targeted solutions to various health issues. We are hosting a special "Ask the Experts" session in Sept to guide you through the global development of your microbiome product. Our regulatory experts specialized in microbiome product development Clara Desvignes and Pauline Lestringant, Ph.D. will answer your questions live on how to leverage regulatory interactions to de-risk microbiome products development in the EU and the US. 🗓 Date & Time: Sept. 19th, 17:00 CET 📢 Format: Online Q&A session 👉 Free registration: https://lnkd.in/edFTFuEi Save your place now! #microbiome #regulatory #webinar
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📢 We are hiring! We are currently looking for talents passionate about life science and there are various job openings at our different office locations! 👉 Check out our career page to view the opportunities: https://lnkd.in/ezNPbgV Paul Kingston
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We are thrilled to share our recent Corporate Social Responsibility (CSR) initiative in India, where we provided funding and resources to two local schools - Sangameshwara School and NSVK Kannada Primary & High School. We are proud to contribute to the educational development of these young minds and look forward to seeing the positive outcomes of this support! Dr. Rajashree Devarakonda, Mireille Blaess, Pavithra Vinod, Satish Reddy P., Anudeep Koduri, Pavan Kumar R Y, Nataraja yadav Perikala, Anand Kumar A #CSR
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