PharmaLex

As the life science industry adapts to the upcoming changes in Health Technology Assessment (HTA) across Europe, a critical challenge emerges: effectively demonstrating the value proposition of innovative products. Cencora puts you at the forefront of navigating the new EU HTA framework. Attend the NLSDays 2024 workshop entitled Investor Gateway to Europe: Demonstrating Innovative Product Value Within Future EU HTAR Framework, happening on 18th September, 10:00 - 11:00, to gain insights on how to optimize your #investment #strategy for success in the new #EU #HTA environment. Register here: https://lnkd.in/d_6sry-N

The European Medicines Agency (EMA) has updated its guidelines on advanced therapy medicinal products (ATMPs), emphasizing a collaborative approach with stakeholders. Key takeaways include: 🧬 Separation of guidelines for Gene Therapy Medicinal Products (GTMPs) and Cell Based Medicinal Products (CBMPs) was suggested but not implemented; 🧬 Updates on stage-appropriate CMC expectations to alleviate high validation demands; 🧬 Clarification on potency assay validation and process evaluation/validation for clinical trials. Check out the full article by Pam Dhadda, Associate Director at PharmaLex, for an in-depth analysis of the changes and their impact on ATMP development in Europe. Read more: https://lnkd.in/dDcaNFVE #PharmaNews #ATMP #GeneTherapy #CellTherapy #PharmaLex #EMA

We are thrilled to welcome our new Managing Directors for Iberia at PharmaLex, Gonzalo Casino as Regional Country Manager for Iberia region and Beatriz Caeiro for Portugal! 🌟 Gonzalo joins us with 24 years of experience in the healthcare sector, having held prominent roles at Deloitte Consulting and the health insurance company, DKV. His leadership, strategic planning, business development skills, and dedication to healthcare education and social causes will be instrumental in steering PharmaLex Spain towards continued growth and success. 🌟 Beatriz brings nearly 30 years of invaluable experience in the pharmaceutical industry, excelling in leadership roles, including as General Manager of Portuguese subsidiaries. Her expertise in sales and marketing, coupled with her multinational experience, makes her the perfect fit to navigate and lead PharmaLex Portugal through our current transformations and beyond. We are confident that their combined leadership will be pivotal in consolidating our strategy and affirming PharmaLex as a leading force in the market. Welcome to the team! 🚀 #PharmaLex #Leadership #Iberia

🎧 Dive into our top 3 #podcasts this summer! 🌞 Check out our top 3 must-listen podcasts this summer: ▶️ https://lnkd.in/d9j4edN9 ▶️ https://lnkd.in/dC-GaP2E ▶️ https://lnkd.in/d9Rf5y4h Tune in and elevate your knowledge! #PharmaLex #QMC #PharmaceuticalIndustry #ExpertInsights Londa R. Stephan Hütter Patrick Nieuwenhuizen

📚 Exciting News! PharmaLex is proud to have Karl-Heinz Loebel as a contributing author in the latest DIA eBook “Achieving Excellence in Regulatory Information Management”. As experts in the industry, we are excited to be part of this publication that provides a comprehensive guide on best practices in regulatory information management (RIM) capabilities and functional interfaces. Join us in uncovering the latest trends and insights in RIM! Get your eBook copy today: https://lnkd.in/dWBNQ5H7 #PharmaLex #RegulatoryAffairs #RIM #NewRelease #eBook #BestPractices #IndustryInsights

🚨 On-Demand Webinar Alert! 🚨 Discover how new technologies are transforming pharmacovigilance and improving patient safety. Join our expert panel, hosted and moderated by PharmaLex, as they delve into the current state of pharmacovigilance technologies with real business use cases. 📅 Available On-Demand 🕒 1 hour 💻 Your Desk! Key learning objectives: 🔹 Transformative pharmacovigilance technologies: from automation to AI 🔹 Business use cases: outcomes and lessons learned 🔹 Evaluating technology projects: critical questions to ask 🔹 Future implications of AI for safety and clinical teams Don't miss this chance to learn how AI and other technologies can enhance your pharmacovigilance processes and boost patient safety. Watch now: https://lnkd.in/dNgmhFBP #PharmaLex #Pharmacovigilance #PatientSafety #AI #MachineLearning #Automation #HealthcareInnovation #Webinar

🌟 Employee Spotlight! 🌟 Today, we are excited to highlight our exceptional team member, Regina Dawkins! 🎙️ 𝗪𝗵𝗮𝘁 𝗮𝗿𝗲 𝘀𝗼𝗺𝗲 𝗸𝗲𝘆 𝗳𝗮𝗰𝘁𝗼𝗿𝘀 𝘁𝗵𝗮𝘁 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗰𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀 𝘀𝗵𝗼𝘂𝗹𝗱 𝗰𝗼𝗻𝘀𝗶𝗱𝗲𝗿 𝘄𝗵𝗲𝗻 𝗮𝘀𝘀𝗲𝘀𝘀𝗶𝗻𝗴 𝘁𝗵𝗲𝗶𝗿 𝗰𝗼𝗺𝗺𝗲𝗿𝗰𝗶𝗮𝗹𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗿𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀 𝗳𝗼𝗿 𝗘𝘂𝗿𝗼𝗽𝗲? Understanding the complexity of the European market and local regulatory requirements is crucial, including identification of the necessary import and distribution licenses to successfully launch product within the EU market. Consideration of proposed fiscal supply chains to meet with regulatory expectations for market supply is key in establishing a compliant supply chain. Be aware that Switzerland and the UK whilst physically located in Europe are not EU countries. 🎙️ 𝗪𝗵𝗮𝘁 𝗮𝗿𝗲 𝘀𝗼𝗺𝗲 𝗰𝗼𝗺𝗺𝗼𝗻 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝘁𝗵𝗮𝘁 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗰𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀 𝗳𝗮𝗰𝗲 𝘄𝗵𝗲𝗻 𝗲𝘅𝗽𝗮𝗻𝗱𝗶𝗻𝗴 𝗶𝗻𝘁𝗼 𝗘𝘂𝗿𝗼𝗽𝗲, 𝗮𝗻𝗱 𝗵𝗼𝘄 𝗱𝗼 𝘆𝗼𝘂 𝗵𝗲𝗹𝗽 𝘁𝗵𝗲𝗺 𝗼𝘃𝗲𝗿𝗰𝗼𝗺𝗲 𝘁𝗵𝗲𝘀𝗲 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀? Understanding the complexity of supplying medicines within European market and the regulatory licences required. With global to local market expertise, PharmaLex can support clients in the navigating complexities of EU, Swiss and UK regulations effectively to enable compliance, minimise risks and support speed to market. We support mapping supply chains and providing local licence expertise and support to successfully obtain local licenses and launch medicinal products within the European market. 🎙️ 𝗖𝗮𝗻 𝘆𝗼𝘂 𝘁𝗲𝗹𝗹 𝘂𝘀 𝗮𝗯𝗼𝘂𝘁 𝗮 𝗽𝗿𝗼𝗷𝗲𝗰𝘁 𝗼𝗿 𝗶𝗻𝗶𝘁𝗶𝗮𝘁𝗶𝘃𝗲 𝘆𝗼𝘂 𝗵𝗮𝘃𝗲 𝗿𝗲𝗰𝗲𝗻𝘁𝗹𝘆 𝗯𝗲𝗲𝗻 𝗶𝗻𝘃𝗼𝗹𝘃𝗲𝗱 𝗶𝗻 𝘁𝗵𝗮𝘁 𝘆𝗼𝘂𝗿 𝗽𝗮𝗿𝘁𝗶𝗰𝘂𝗹𝗮𝗿𝗹𝘆 𝗽𝗿𝗼𝘂𝗱 𝗼𝗳? Supporting a US company successfully gain MA approval and launch with the European market by navigating them through the process from MA application, European entity establishment, local licence support, QMS design and development, Qualification of Outsourced activities, staff augmentation, inspection support and successful supply of product to patient. 🎙️ 𝗪𝗵𝗮𝘁 𝗮𝗱𝘃𝗶𝗰𝗲 𝘄𝗼𝘂𝗹𝗱 𝘆𝗼𝘂 𝗴𝗶𝘃𝗲 𝘁𝗼 𝘀𝗼𝗺𝗲𝗼𝗻𝗲 𝘄𝗵𝗼 𝗶𝘀 𝗰𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗶𝗻𝗴 𝗮 𝗰𝗮𝗿𝗲𝗲𝗿 𝗶𝗻 𝘁𝗵𝗲 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝘆? A career in the pharmaceutical industry is rewarding, offering development, growth, and job satisfaction while supporting patient safety. Start hands-on in a lab or manufacturing facility to understand processes and systems, enhancing problem-solving skills. Get involved in auditing early to expand your knowledge and expertise, as good auditing skills are invaluable and support an inquisitive mind. 🔗 Learn more about our team's work: https://lnkd.in/e_2XZwqt #PharmaLex #TeamSpotlight #PharmaceuticalIndustry #QMC

Resta sempre aggiornato sulle novità del mondo health. Il team Public Affairs e il team Media&PR selezionano per te le notizie più importanti della settimana dal mondo delle istituzioni e dei media. Sfoglia lo slideshow e buona lettura! #pickoftheweek #news #publicaffairs #comunicazione

🔍 Stay ahead in clinical trial management with insights from our latest blogs by Aaron Grant - VP of Solutions Consulting at PharmaLex! 1️⃣ How AI Can Support the Trial Master File: Learn how artificial intelligence is revolutionizing TMF management, enhancing accuracy and saving time. Read more here: https://lnkd.in/d2FRiFCz 2️⃣ Staying on Top of the Trial Master File: Discover key strategies to efficiently manage your TMF, ensuring compliance and streamlined processes. Read more here: https://lnkd.in/diMwVa5i Don't miss out on these expert insights—read now and elevate your TMF management game! 👇 #ClinicalTrials #TMF #ArtificialIntelligence #Compliance #PhlexGlobal

Join our panel of experts for an insightful session on “Unlocking the Secrets of Managing CTR in a Complex Development Landscape.” They’ll address your questions live, share practical advice, and provide real-life examples to help you navigate the intricacies of Clinical Trial Regulation (CTR)! 🗓️ Date: July 24th, 2024 ⏰ Time: 5 pm CEST / 4 pm BST / 11 am EDT Don’t miss out! Register today: https://lnkd.in/dhHqXHmy #ClinicalTrialRegulation #RegulatoryCompliance #PharmaLex #Webinar Xandra Neuberger Dr. Carolin Gloger Dr. Berit Bachmann, M.D.R.A. Feel free to share this exciting event with your network! 📢