Monique Berwaer

🩺 Are you looking to improve your understanding and ability to start a #biologic treatment, follow up with the #patient, and evaluate the success of treatment? EUFOREA hosted its first edition of the European Biologics Training Course on 1 March 2024 at the Académie royale de Médecine de Belgique in #brussels with more than 250 attendees worldwide. A hybrid training course designed to increase engagement and understanding of #biologics among healthcare professionals (ENT specialists, pulmonologists, and allergologists) treating patients with uncontrolled type 2 diseases including #asthma, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Atopic Dermatitis (AD). Watch the European Biologics Training Course now and earn your #CME accreditation! 🔗 https://lnkd.in/ejmBkbn4 #eubiologics24 #health #healthcare #healthprofessionals #patients #patientcare #airwaydiseases #chronicdiseases #physicians #trainingcourse #trainingprogram #events2024 #nasalpolyps #asthmaawareness #treatment #ent #nonprofit #euforea #belgium #clinicians #pulmonologist #allergologist #atopicdermatitis #cmecredits

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Did you know that 60% of Belgians say they are ready to participate in a clinical study? On #WorldClinicalTrialDay, we are proud to unveil significant findings from our #survey in our new blog post. Dive into the data as we explore trends and insights on the behavior of Belgian people toward #clinicaltrials. #PatientEngagement #BelgianHealthcare EN: https://t.ly/o8OBA FR: https://t.ly/hXcLX NL: https://t.ly/vIknq

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Today we celebrate #WorldClinicalTrialDay 🔬 Did you know that 60% of Belgians say they are ready to participate in a clinical study? Discover more insights on clinical trials in Curewiki's latest blog post. 💡

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- Challenges of Regulatory Compliance for Device Companies For full vidéo check: https://lnkd.in/erC7jQ9p Erik Vollebregt Monir El Azzouzi #medicaldevice #easymedicaldevice #regulatoryaffairs #podcast #eucommission

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🌟Computerised Systems and Electronic Data in Clinical Trials🌟 Our CEO, Jelle ten Hoeve, will attend a workshop to learn the requirements of software suitable for clinical trials. We are steadily advancing the TIDE (https://tide.nki.nl/) technology for clinical utility, developing TIDE GxP and participating in events like this. Event details: ISPE Event - https://lnkd.in/erDhBivH #ClinicalTrials #CRISPR #Bioinformatics #TIDEGxP #GeneEditing

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🌟 Galapagos, a Flemish biotech company, has made a significant advancement by partnering with Adaptimmune to 𝐝𝐞𝐯𝐞𝐥𝐨𝐩 𝐧𝐞𝐱𝐭-𝐠𝐞𝐧𝐞𝐫𝐚𝐭𝐢𝐨𝐧 𝐓-𝐜𝐞𝐥𝐥 𝐭𝐡𝐞𝐫𝐚𝐩𝐲 𝐢𝐧 𝐚 𝐝𝐞𝐚𝐥 𝐯𝐚𝐥𝐮𝐞𝐝 𝐚𝐭 $𝟔𝟔𝟓 𝐦𝐢𝐥𝐥𝐢𝐨𝐧 𝐢𝐧 𝐛𝐢𝐨𝐛𝐮𝐜𝐤𝐬! This collaboration focuses on uza-cel, a MAGE-A4 TCR T-cell therapy initially designed for ovarian cancer. Galapagos plans to extend its application to head and neck cancer and other solid tumors. 🚀 Dr. Paul Stoffels, MD, Galapagos’ Chief Executive Officer and Chairman, stated: “𝑇ℎ𝑖𝑠 𝑐𝑜𝑙𝑙𝑎𝑏𝑜𝑟𝑎𝑡𝑖𝑜𝑛 𝑜𝑓𝑓𝑒𝑟𝑠 𝑡ℎ𝑒 𝑝𝑟𝑜𝑚𝑖𝑠𝑒 𝑓𝑜𝑟 𝑓𝑎𝑠𝑡𝑒𝑟 𝑎𝑐𝑐𝑒𝑠𝑠 𝑡𝑜 𝑎 𝑝𝑜𝑡𝑒𝑛𝑡𝑖𝑎𝑙𝑙𝑦 𝑡𝑟𝑎𝑛𝑠𝑓𝑜𝑟𝑚𝑎𝑡𝑖𝑣𝑒 𝑡𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡.” 🤝 The funding from this deal ensures the continuation of uza-cel's development and supports the launch of Adaptimmune's leading asset, afami-cel, for synovial sarcoma later this year. Adrian (Ad) Rawcliffe, Adaptimmune’s Chief Executive Officer, noted: “𝐶𝑜𝑚𝑏𝑖𝑛𝑖𝑛𝑔 𝑢𝑧𝑎-𝑐𝑒𝑙 𝑤𝑖𝑡ℎ 𝐺𝑎𝑙𝑎𝑝𝑎𝑔𝑜𝑠’ 𝑢𝑛𝑖𝑞𝑢𝑒 𝑑𝑒𝑐𝑒𝑛𝑡𝑟𝑎𝑙𝑖𝑧𝑒𝑑 𝑚𝑎𝑛𝑢𝑓𝑎𝑐𝑡𝑢𝑟𝑖𝑛𝑔 𝑝𝑙𝑎𝑡𝑓𝑜𝑟𝑚 𝑖𝑠 𝑎 𝑛𝑎𝑡𝑢𝑟𝑎𝑙 𝑠𝑦𝑛𝑒𝑟𝑔𝑦.” 📈 The news has positively impacted Adaptimmune's market performance, with a 21% surge in premarket trading. This collaboration underscores the 𝐢𝐦𝐩𝐨𝐫𝐭𝐚𝐧𝐜𝐞 𝐨𝐟 𝐢𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐩𝐚𝐫𝐭𝐧𝐞𝐫𝐬𝐡𝐢𝐩𝐬 𝐢𝐧 𝐚𝐝𝐯𝐚𝐧𝐜𝐢𝐧𝐠 𝐢𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐯𝐞 𝐭𝐡𝐞𝐫𝐚𝐩𝐢𝐞𝐬, celebrated by entities like Flanders Investment & Trade (FIT). 📰: Fierce Biotech, flanders.bio  📸: Labiotech.eu 

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📢 IVDR- IMPORTANT MDCG released : MDCG 2024-4 Safety reporting in performance studies of invitro diagnostic medical devices under regulation (EU) 2017/746 ⭕ Safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) shall be performed in line with the requirements of Article 76(2) of Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation (IVDR) ⭕The reporting modalities and format set out in this guidance apply to: Performance studies covered by IVDR Article 58(1): ➰in which surgically invasive sample-taking is done only for the purpose of the performance study; ➰that is an interventional clinical performance study as defined in IVDR Article 2(46); ➰ where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies; ➰performance studies covered by IVDR Article 58(2) involving companion diagnostics (except when only using left-over samples); ➰ PMPF studies covered by IVDR Article 70(1) that involve procedures additional to those performed under the normal conditions of use of the IVD and where those additional procedures are invasive or burdensome, in case a causal relationship between a SAE and the preceding performance study has been established; ➰performance studies covered by IVDR Article 70(2) that are conducted to assess, outside the scope of its intended purpose, an IVD that already bears the CE marking. ➰combined studies of medicinal products and IVDs. When the study satisfies the definition of a performance study of an IVD, regardless of whether it is conducted in the context of a clinical trial of a medicinal product, the requirements of the IVDR and including its safety reporting obligations apply to the study. This guidance document is then relevant for compliance with the IVDR regarding safety reporting. ⭕ Note: MDCG 2022-10 provides further guidance on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and the IVDR. https://lnkd.in/eFddqz9Y 📢 📢VERY IMPORTANT: The Performance Study Summary Safety Reporting FORM that you will need to use. https://lnkd.in/dKznzgsi

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How to define good practice for clinical performance studies of IVD medical devices when specimens from human subjects are used? BS EN ISO 20916:2024 explains all you need to know to ensures safe, reliable clinical studies & EU IVDR compliance. Discover: https://bit.ly/3Tvdi8A #BSI #MedicalDevices #BSIStandards #ISO20916 #IVDs #ClinicalPerformanceStudies

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How to define good practice for clinical performance studies of IVD medical devices when specimens from human subjects are used? BS EN ISO 20916:2024 explains all you need to know to ensures safe, reliable clinical studies & EU IVDR compliance. Discover: https://bit.ly/3Tvdi8A #BSIStandards #ISO20916 #IVDs #ClinicalPerformanceStudies

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- Insights on Correct Data Collection and Validation. For full episode check: https://lnkd.in/ebtvrARx Monir El Azzouzi Amandine Broussier #easymedicaldevice #medicaldevice #regulatorycompliance

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Did you know... The Belgian Medicines Agency, FAGG, introduced a new type of submission file for Risk Minimization Activities (RMA), allowing for purely administrative updates at reduced fees. This facilitates faster and more cost-effective updates for minor changes to the RMA. Want to know how this may impact your procedures? iViReg leverages hundreds of local experts in 90+ countries to provide interpretations and impact assessment of regulatory changes just like these. Book a free trial today: https://lnkd.in/e_aUeUag #regulatoryintelligence #pharmacovigilance #drugsafety #belgium

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👉🏼 Regulatory news 𝗦𝘄𝗶𝘁𝘇𝗲𝗿𝗹𝗮𝗻𝗱 ▶ Swiss Medical Device Ordinance (SR 812.213) MedDO applies to products without intended medical purpose listed in Annex 1 of the MedDO (so-called “Annex XVI products” https://lnkd.in/e8gU-Zmx, by reference to the respective EU MDR annex) from 1-May-2024. ▶ This date is almost one year later than the date of application of the EU MDR to Annex XVI products, i.e. 22-Jun-2023, because Switzerland implemented the requirements and transitional provisions with some delay, in the revision of the MedDO published on 1-Nov-2023. ▶ However, the transitional periods in the MedDO are aligned with those in the EU MDR, i.e. 31-Dec-2029 if the devices have ongoing/planned clinical investigations or 31-Dec-2028 if they do not. ▶ Products not marketed in Switzerland by 1-May-2024 cannot benefit from the transitional provisions. 👉🏼 Learn more about the situation of Annex XVI products in Switzerland from Swissmedic’s dedicated website: https://lnkd.in/eRJT6ZX5 👉🏼 More news on #medicaldevice #regulation from us: https://lnkd.in/eHs3khty #MedDO #IvDO #RegulatoryAffairs #Switzerland #SwissMedtech #Swissmedic #Decomplix

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Is the new Clinical Trials Regulation threatening Belgium's clinical trial efficiency? Check out this article to discover the strategies Belgian early-phase units are employing to adapt and thrive in this changing landscape. 👉 Read article https://bit.ly/49xmbo1 #clinicalresearch #SGSCPU

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How can medical device manufacturers comply with EU MDR activities in the most cost-effective ways? Our experts discuss balancing compliance against cost in Med Device Online ⬇️

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How can automated processes help with the daily operational tasks? Let's find out how G-Flex Europe SPRL benefits from it. 👇 G-Flex is a manufacturer in Medical Devices, specialised in diagnostic and therapeutic attachments for the gastrointestinal and pulmonary markets. Being recently acquired by the American company Diversatek, G-Flex has manufacturing and distribution sites around the 🌎. Thierry CREMER, QA/RA Director & PRRC at G-Flex, explains how Bizzmine's platform Bizzmine’s cloud-based access is crucial for their divisions in South America and Europe, enhancing operational efficiency. Let's watch! 📽️ #business #automation #customertestimonial

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VECTORB2B IS NOW MEMBER OF EUROPHARM SMC, The European Pharmaceutical Association representing Small and Medium Sized Pharmaceutical Companies. Europharm's mission is to support and defend the interests of SMEs, in order to enhance their competitiveness and entrepreneurship within the global framework of the pharmaceutical industry. Europharm SMC is a unique business network of pharmaceutical SMEs coming from all European countries who share this common goal. The association has its own staffed office, located in Brussels, Belgium. Whereas on the one hand, globalisation and networking are key words for success, on the other, SMEs need additional factors to meet their challenges, such as swifter information exchange, new partners, and logistic support in R&D, product registration and pharmaceutical manufacture and distribution. Based on R&D Portfolio Management Services, VECTORB2B has the resources to deliver a detailed plan for Small and Medium sized Pharmaceutical Companies as well as to execute it till the desired solution. VectorB2B R&D Strategic Consulting Services can offer a new perspective and approach through R&D Support, Reformulation, Repurposing, New Products.

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📢Exciting news! The COVend project’s IXION 2.0 Clinical study is currently underway, with patients being enrolled at our clinical sites in Germany, France, Spain and Lithuania. The IXION 2.0 clinical trial is a crucial component of the COVend consortium’s efforts to develop an effective therapy against endothelial damage in Acute Respiratory Distress Syndrome, particularly in mild and moderate stages. Over the next few weeks, we will be sharing Frequently Asked Questions (FAQs) to provide valuable insights, address common inquiries about the IXION 2.0 clinical study, and highlight the remarkable efforts of our dedicated team of researchers and clinicians during this study. Let’s get to it with our first FAQ! 🌟 FAQ #1: What is a clinical trial? A clinical trial is a specific type of study that investigates the impacts of a specific treatment on a certain group of patients. This type of study consists of one group receiving a specific treatment (intervention group) compared to a group receiving normal treatment (control group). The goal is to determine if the intervention group shows any advantages over the control group. Here’s how it works:   🔍 Observational Studies: These studies observe people in their natural settings, collecting information over time. For instance, researchers might track exercise habits in older adults and correlate them with cognitive health. While observational studies don’t test medical interventions directly, they help identify potential treatments or prevention strategies to explore further.   🩺 Clinical Trials: These research studies actively test medical, surgical, or behavioural interventions in people. They’re the primary way researchers determine if a new treatment or prevention method (like a novel drug, diet, or medical device) is both safe and effective. Clinical trials often compare the intervention group (receiving the new treatment) to the control group (receiving standard treatment). You may find more information on clinical studies here: Learn about Clinical Trials in general here 👉 https://lnkd.in/d488vFnF For more details about the IXION 2.0 study, please visit COVend website:🌐🔬 👉https://lnkd.in/eem5FF-u #COVend #FAQ #IXIONClinicalTrial #ClinicalTrial #MedicalResearch #HorizonEurope #HorizonEU #EUproject #ARDS Goethe University Frankfurt - Universitätsklinikum Frankfurt Greater Paris University Hospitals - AP-HP Hospital Universitari de Bellvitge The Hospital of Lithuanian University of Health Sciences Kauno klinikos

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