Fortrea’s Post

📚 𝗗𝗿𝘂𝗴-𝗗𝗲𝘃𝗶𝗰𝗲 𝗰𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀 𝗶𝗻 𝗘𝗨 𝗮𝗻𝗱 𝗨𝗦 🗓 27&28 November 2024 | Online The training course will explore the EU and US regulatory landscape defining the key differences, and similarities, and provide an overview of the regulatory pathways and how to successfully navigate between drugs, devices, and combination products in each jurisdiction. 🎓Tina Amini, TA MedTech & Combination Products Consulting Ltd 👉 Leggi il programma completo: https://shorturl.at/prUni

🔬Sharing latest draft guideline: "Quality Requirements for Investigational Advanced Therapy Medicinal Products (ATMPs) in Clinical Trials." It's a comprehensive resource covering development, manufacturing, quality control, and more for ATMPs. Ensuring safety and efficacy every step of the way! #ClinicalTrials #ATMPs #Healthcare #QualityAssurance #Zenovel

Did you know that the #EUGMP #Annex1 Manufacture of Sterile Medicinal Products was revised in 2022? 📝 💊 The update aims to eliminate ambiguities and inconsistencies while taking technological advances into account. But that's not all! The revised version is now better structured, with 11 clear sections. 🔍✔️ We've provided a summary of the changes and our initial insights several months after the revision in this blog post. 👇 https://hubs.li/Q02jr-cL0 #GMP #MedicinalProducts

Attending the GIRP Supply Chain Conference in Lisbon has been insightful. Day 1 addressed key challenges like medicine shortages and counterfeit products in the legal pharma supply chain, with a notable example being Ozempic—directly relevant to Bonafi’s mission of ensuring compliance and integrity in the pharma supply chain. Today is focused on innovation in pharma, sustainability, and medicine stockpiling. It is great to hear from engaging speakers, including regulators, and to make new connections while discussing these important issues. #GIRPSCC #pharma #bonafi #compliance

Are you ready for the changes outlined in the EU HTAR’s recently published draft Joint Clinical Assessment (JCA) for medicinal products Implementing Act (IA)? Capture the insights: https://ow.ly/jyV850TkAXq. The first of six IA’s outlined by EU HTAR, the JCA builds on the outcomes and documents produced by EUnetHTA joint actions and the more recent EUnetHTA 21 service contract. Find out what the draft JCA IA covers – and what it does not – in this illuminating deep dive in partnership with IQVIA.

Useful info on JCAs from Remap!

❕EMA News: Quality Working Party Work Plan Now Available The European Medicines Agency (EMA) has released the 3-year work plan for the joint CHMP/CVMP Quality Working Party covering the period from 2024 to 2026. This plan outlines strategic goals, tactical activities, and operational objectives related to quality matters for medicinal products containing chemical active substances or medical devices with chemical active substances. Additionally, the EMA has published new Questions and Answers for biological medicinal products. You can find more details in the work plan here 👉https://zurl.co/Nxei #EMAupdates #Lifescience #Lifesciencenews #news #regulatoryupdates

🌿 𝐓𝐡𝐞 𝐟𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐜𝐚𝐧𝐧𝐚𝐛𝐢𝐬 𝐭𝐞𝐬𝐭𝐢𝐧𝐠 𝐢𝐬 𝐞𝐯𝐨𝐥𝐯𝐢𝐧𝐠, 𝐚𝐧𝐝 𝐰𝐢𝐭𝐡 𝐢𝐭, 𝐭𝐡𝐞 𝐧𝐞𝐞𝐝 𝐟𝐨𝐫 𝐫𝐨𝐛𝐮𝐬𝐭 𝐚𝐧𝐝 𝐫𝐞𝐥𝐢𝐚𝐛𝐥𝐞 𝐪𝐮𝐚𝐥𝐢𝐭𝐲 𝐜𝐨𝐧𝐭𝐫𝐨𝐥 𝐬𝐲𝐬𝐭𝐞𝐦𝐬. 🌍 As the global cannabis sector continues to expand, developing comprehensive regulatory frameworks is essential to ensure patient safety and a transparent supply chain. 🔍 The Cannabis Testing Report offers a clear pathway to achieving global standardization in cannabis testing. This is crucial for safeguarding patient health and fostering a secure global supply chain. At NIRLAB, we’re proud to be at the forefront of this evolution. Our advanced near-infrared (NIR) technology provides rapid, accurate, and non-destructive testing methods. This ensures consistent product quality and compliance with evolving regulations, all while reducing costs and time-to-market. As the industry becomes more sophisticated, NIRLAB is committed to playing a crucial role in harmonizing quality control systems globally. #CannabisTesting #QualityControl #NIRLAB #PatientSafety #GlobalStandards #CannabisIndustry #Cannabis #NIR #NearInfraRed

Not all SMEs are ‘small’!! If your company has a turnover of €50m or less, you may be eligible for SME status, benefitting from… - 90% off the cost of a Scientific Advice meeting, saving up to €93k - Early dialogue with a multidisciplinary EMA team - Regulatory strategy advice for product development - Scientific Advice meeting with the MHRA for free, saving up to £5k (if turnover is under £36m) Fusion Pharma can support you in gaining SME status with MHRA and/or EMA – and we provide this for free! Use our simple SME eligibility tool to check if you would qualify for SME status: http://ow.ly/KT8w50OgZ3T #FusionPharma #RegulatorySME #RegulatoryExperts #RegulatoryAffairs

Are you launching in Europe? Do you have a European value dossier ready to support country affiliates? Will your evidence and messaging meet the needs and nuances of the diverse markets? We have experts dedicated to the development of value dossiers for European (and Global!) markets. We can help at every stage, from early strategy, research, and analysis, to evidence generation, crafting your value story, and writing the final dossier. We even have a digital platform specifically designed to host value dossiers and supporting evidence for multiple markets. Want to learn more? Drop us an email at info@mtechaccess.co.uk to arrange a no-obligation consultation call with our experts, or visit https://lnkd.in/eeUrtYSw #Europeanvaluedossier #valuedossiers #marketaccess #evidence #HEOR #HTA #reimbursement #Pharma #medicaldevices