Subscribe now to our 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 𝗤𝘂𝗮𝗿𝘁𝗲𝗿𝗹𝘆 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿 and get the latest #MedTech news and events from our PharmaLex team. Register here: 🔗 https://lnkd.in/d9W9Asc7 Join our community today and stay ahead in the rapidly evolving #MedTech industry. #CencoraPharmalex
PharmaLex
Arzneimittelherstellung
Beyond the science | using technology-enabled services to accelerate decision making and drive efficiency gains
Info
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!
- Website
-
http://www.pharmalex.com
Externer Link zu PharmaLex
- Branche
- Arzneimittelherstellung
- Größe
- 1.001–5.000 Beschäftigte
- Hauptsitz
- Bad Homburg
- Art
- Privatunternehmen
- Gegründet
- 1994
- Spezialgebiete
- Regulatory Affairs, Pharmacovigilance, Regulatory Operations, Pharmaceutical Quality, Audit / Inspection Preparation, Medical Writing, Biostatistics, Medical Devices, Risk Mangement, Development Consulting, GxP services und Clinical Trial
Orte
Beschäftigte von PharmaLex
Updates
-
Explore PharmaLex's insights on the EU's updated SoHO legislation and its impact on ATMPs! Tiina Palomäki, Director and Principal Consultant, delves into the key changes and implications: ☑️ Unified Regulation: Blood products, tissues, and cells now fall under one regulation. ☑️ Extended Scope: Includes intestinal microbiota, breast milk, and future human-derived materials. ☑️ Enhanced Oversight: Establishment of national authorities and an EU SoHO coordination board. ☑️ Broadened Compliance: Impacts all activities from donor registration to clinical outcome registration. Read the full article here: https://lnkd.in/d-DjS9ep #SoHO #EURegulations #ATMPs #PharmaLex #HealthcareInnovation #RegulatoryAffairs #MedicalDevices
-
🚨 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
-
Discover new efficiencies in document processing with our on-demand webinar: Document Processing: A New Hope! 🕒 Available anytime, anywhere. 💼 Learn cutting-edge techniques to boost speed and improve "right-first-time" quality. 💡 Discover how top-performing companies are leading the way. Watch now and revolutionize your document management: https://lnkd.in/dCgpfwbV #PharmaLex #DocumentProcessing #ProfessionalServices #TMFOperations #QualityImprovement
-
Gain insights from industry experts Dennis Earle, Dr. Christian K Schneider, and Joerg Schneider as they delve into the complexities of regulatory frameworks for targeted therapies. Key takeaways include: 🔹 The importance of engaging with regulatory agencies early. 🔹 How expert guidance can streamline the approval process. 🔹 Mitigating risks and enhancing credibility through collaboration. 🔹 Navigating global regulations with experienced authorities. Full article here: https://lnkd.in/dzWJGEwi #PharmaLex #TargetedMedicines #RegulatoryCompliance #Biopharma #Innovation #Healthcare #ExpertGuidance
-
#3 SUMMER SHORTS: House of the Inspector Join us on tomorrow, August 13th, at 4:00 PM CET for a must-attend webinar! TMF inspectors don’t always breathe fire – but they will if you’re not thoroughly prepared. Findings can lead to trial delays and increased costs. Learn key steps to not just survive an inspection, but to take the TMF Throne! 👑 ⏰ Duration: 30 min Secure your spot and be inspection-ready: https://lnkd.in/dHmEwnXc #PharmaLex #Webinar #TMFExcellence
-
Unlock the secrets to flawless site inspection readiness with Louise Uí Fhatharta! In this episode of PharmaLex Talks, we dive deep into the essential steps for ensuring your site is inspection-ready. With over 20 years of experience in Microbiology, Quality Control, and Quality Assurance, Louise shares her invaluable insights from leading FDA, HPRA, and DEKRA Health Authority inspections. Don't miss out on this expert guide to operational readiness and compliance. Tune in now to gain the knowledge you need to excel in your industry! 🎧 Listen here: https://lnkd.in/dHSsM8Bh ⏱️ Duration: 18 minutes #PharmaLex #PharmaLexTalks #Podcast #PharmaceuticalIndustry #QualityAssurance #InspectionReadiness
-
What an incredible session at #JSM2024 in Portland discussing the regulatory acceptability of Bayesian methods! A huge shoutout to our team members Martina Fortin, Lauren Frazee, PhD, Brad Carlin and our brilliant speakers John Scott and Freda Cooner from FDA , Amy Xia from Amgen, Lauren Frazee, PhD from PharmaLex, and Ruitao Lin from MD Anderson Cancer Center. The future of Bayesian methods in US and international regulatory science is truly promising! Learn more about Statistics & Data Science at PharmaLex here: https://lnkd.in/gxRQJ48n #BayesianMethods #RegulatoryScience #PharmaLex #DataScience
-
Unlock the future of personalized medicine with insights from Dr. Christian K Schneider in his latest article on targeted therapies! Key takeaways include: ✅ The revolutionary impact of targeted medicines on patient outcomes. ✅ How biomarkers and companion diagnostics (CDx) connect life-saving therapies ✅ The critical role of AI and machine learning in advancing precision medicine. ✅ Navigating regulatory pathways for successful approval and delivery. ✅ The importance of collaboration between developers, diagnostic teams, and regulators. Explore the full article here: https://lnkd.in/dQhNng8V #PharmaLex #TargetedMedicine #TargetedTherapies #Biomarkers #CompanionDiagnostics #RegulatoryAffairs #PharmaceuticalInnovation
-
PharmaLex hat dies direkt geteilt
Happy to be at #JSM2024 in Portland with the other members of the Cencora-PharmaLex "dream team", Martina Fortin and Lauren Frazee, PhD! We're here for one more day; if you're in Portland, please stop by Booth 310 in the convention center Expo, say hello, and pick up some cool swag!