#PharmaLexInTheField! 🚀🌍 This week, we’re thrilled to highlight the TOPRA Symposium 2024! 🔹 TOPRA Symposium 2024 | September 30 - October 2, 2024 | Rotterdam, Netherlands 🎙️ Meet our team at booth #33 🔗 Register here: https://lnkd.in/dSdZBU3Q Join us for an insightful event dedicated to healthcare regulatory affairs, featuring streams for human medicines, medical devices, IVDs, and veterinary medicines. Don’t miss the chance to network and gain new contacts! Our Team: • Tiina Riihimäki - Director, International Service Lead (ISL) Europe Medical Device Services • Nadège Cartier - Regional Sales Manager • Pirkko Talvio, Senior Director, Head of Regulatory Affairs Nordics • Nina Andersson, Business Development Manager • Kenneth Hollmén, Senior Manager, Regional Sales • Trevor Brett, Director, Business Development, DCS – Europe We look forward to connecting and sharing insights during the event. See you there! #PharmaLex #Events #GlobalExpertise #NetworkingEvents
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PharmaLex is one of the largest providers for Development Consulting, Regulatory Affairs, Quality Management & Compliance, Pharmacovigilance, Epidemiology, and Risk Management worldwide. Our global teams of experts can take you through early strategic planning activities and nonclinical requirements to clinical development, through regulatory submission processes and finally guide you to market approval and product maintenance post-launch activities. Through our worldwide offices, we provide flexible and cost-effective service models. Looking for local expertise with global reach? Contact us, to find out more!
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http://www.pharmalex.com
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Updates
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Hear from our expert speaker at World Drug Safety Congress Europe next week at RAI, Amsterdam! 📅 Date: Thursday, 10 October 2024 🕒 Time: 12:05 – 12:15 PM 🗣️ Speaker: Alex Brenchat, VP, Local Pharmacovigilance Services, PharmaLex 🔍 Topic: "Best Practices When Outsourcing Pharmacovigilance Services at the Local and Regional Level" 📍 Location: PV Outsourcing, G109 Who Should Attend? PV managers, regulatory affairs professionals, and PV outsourcing decision-makers. Join our Vice President of Local #Pharmacovigilance Services, Alex Brenchat, at the World Drug Safety Congress Europe for an authoritative overview of best practices for effectively managing PV outsourcing across diverse geographies. Drawing on real-world examples and case studies from leading pharmaceutical companies, this key session will guide you through common challenges and offer practical recommendations on regulatory compliance, risk management, and provider selection. You will discover: 🔹 The importance of tailored strategies to address local regulatory requirements and market dynamics 🔹 Critical PV outsourcing considerations – from understanding local regulatory landscapes to maintaining clear communication channels 🔹 How to navigate vital factors such as vendor selection, contract management, and establishing robust oversight mechanisms Attendees will leave with actionable insights and tools to optimize #PV #outsourcing strategies at both local and regional levels, ensuring patient safety and regulatory compliance while achieving operational efficiency. Register here: https://lnkd.in/d4D43dUc #WorldDrugSafety #WDSEurope #PharmaLex
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Curious about the regulations for companion diagnostics in the EU, US, and Australia?🌍🧬 CDx regulatory requirements can vary significantly across these regions. Successfully navigating these complexities is crucial for a smooth commercialization journey. Discover how PharmaLex’s expert team can guide your CDx project through every stage of its lifecycle. 🔗 https://lnkd.in/gpVm8W2 #CDx #MedTech #CompanionDiagnostics #PharmaLex
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Explore “Considering possible PICOs early on in clinical development is crucial” by Annabelle Forsmark & Ruairi O'Donnell. Learn how early PICO consideration can streamline trials and enhance outcomes. The advancement of bioinformatics has allowed an explosion in the field of precision medicine over the last decade, making it more crucial than ever to consider PICOs early on. Read the complete article published by Nordic Life Science News: https://lnkd.in/gS7dNzwU #ClinicalDevelopment #PICOs #PharmaLex #LifeScience #HealthcareInnovation
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Elevate your quality management and compliance with PharmaLex! Our expert team ensures your systems meet regulatory standards and follow GxP guidelines. From consultancy to risk management, we've got you covered. Watch our video to learn more about our comprehensive services. Contact Us: https://lnkd.in/gpVm8W2 Learn more about QMC: https://lnkd.in/e_2XZwqt #PharmaLex #QualityManagement #Compliance #GxP #RegulatoryAffairs #Healthcare #RiskManagement #SOPs #Audits #Inspections #Remediation
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Join our upcoming webinar "Alternative Submission Pathways Explored" on October 23rd! Discover the ins and outs of Access Consortium and Project Orbis with our expert panel from PharmaLex: 🔹 Piety Rocha: Director Regulatory Affairs, Australia 🔹 Dr. Laura Boteanu-Jotzu: Director, Head of Regulatory Affairs Team, Frankfurt 🔹 Patrick Larcier, PharmD, MBA: Senior Director Gain valuable insights on: 🔸 When to leverage these pathways 🔸 Key steps before submission 🔸 How these pathways operate and their benefits Register here: https://lnkd.in/d2urVzct #Webinar #Pharma #RegulatoryAffairs #AccessConsortium #ProjectOrbis #MarketAccess #PharmaLex
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Stay Ahead with PharmaLex’s October Newsletter! 🔍 Discover the latest regulatory and analytical developments transforming the life sciences industry. From the groundbreaking European AI Act to the evolution of pharmaceutical outsourcing, our October newsletter covers it all. Highlights include: • Europe’s comprehensive AI Act and its impact on life sciences • Addressing regulatory divergence in EU combined studies • Insights into the next phase of pharmaceutical outsourcing • Leveraging transcriptomic data for precision medicine • Navigating the transition to Clinical Trial Regulation (CTR) #PharmaLex #LifeSciences #RegulatoryUpdates #AIAct #PharmaceuticalOutsourcing #PrecisionMedicine #ClinicalTrials #Newsletter
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📢 The MHRA has released comprehensive details on the Windsor Framework for UK medicines, effective January 1, 2025. Debbie Harrison provides insights on how this framework will ensure that patients in Northern Ireland have access to medicines in the same packaging as the rest of the UK. Read the full article: https://lnkd.in/daFjRmBK #PharmaLex #MHRA #WindsorFramework #UKMedicines #RegulatoryAffairs
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Join us at the 2024 CDISC TMF US Interchange on October 23-24, 2024! This is your chance to share progress, implementation experiences, and strategic ideas on worldwide data interchange standards for medical research. 📍 Location: Doubletree Resort Paradise Valley-Scottsdale, Arizona Don’t miss our session, “Press Start: Initiating Your TMF Set-Up Adventure,” with Marcin Hernik and Erin Markle on October 23, from 13:30 to 14:00! Register now: https://lnkd.in/drnhmEkm Meet our team: Rob Jones, Sage Woodrow, Seth Pearl, Jamie Koehler & Dave Stephens. #TMF #CDISC #PharmaLex #Conference #Networking
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Discover the essential steps to achieving commercialization readiness in Europe with Frederic Pailloux's comprehensive article, "Key Steps to Commercialization Readiness in Europe". Gain valuable insights into regulatory considerations, reimbursement strategies, and market access planning. Ensure your business is prepared for the European market. Read the full article here: https://lnkd.in/da6BWbqQ #Commercialisation #MarketReadiness #EuropeanMarket #BusinessStrategy #PharmaLex