Embark on a global journey with our experts as we dive into another thrilling week of #PharmaLexInTheField! 🚀🌍 This week, we will be attending two major events: 🔹 OCRA Annual 2024 | August 1-2, 2024 | Huntington Beach, USA 🎙️ Speakers: John Lockwood & Stephen Sun 📍 Attendees: Tiina Riihimäki & Piet Lesage 🔗 Learn more: https://lnkd.in/dAtGeXuK 🔹 2024 Joint Statistical Meeting (JMS) | August 3-8, 2024 | Portland, Oregon 🎙️ Speakers: Brad Carlin & Lauren Frazee, PhD 📍 Attendee: Martina Fortin 🔗 Learn more: https://lnkd.in/dXKimD8U Don't miss out on these enriching opportunities to connect, learn, and grow! #PharmaLex #Events #GlobalExpertise #NetworkingEvents
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
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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
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🌞🎧 Dive into the essentials of the EU Annex 1 Revision this summer! In this insightful episode, Patrick Nieuwenhuizen outlines the major changes and provides guidance on how the industry can effectively implement the new Annex 1. Don't miss out on this valuable knowledge! Listen now: https://lnkd.in/d9Rf5y4h #PharmaLex #QMC #Podcast #Annex1 #PharmaceuticalIndustry #ExpertInsights
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Discover the latest insights in our new article "Navigating the TGA’s Requirements for Combination Products" by Piety Rocha and Heyam Kalla. Explore how combination products are revolutionizing healthcare, enhancing patient safety, and improving therapeutic outcomes. Read the full article here: https://lnkd.in/dDSamESx #PharmaLex #RegulatoryAffairs #MedicalDevices #CombinationProducts #PharmaceuticalIndustry #TGA
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#1 SUMMER SHORTS: Document Processing: A New Hope Join us tomorrow, July 30th, at 4:00 PM CET for our first Summer Shorts: #TMF Excellence Edition! Discover how new techniques are boosting document processing speed and improving quality – all while reducing costly remediation. Learn from top-performing companies and enhance your TMF practices! ⏰ Duration: 30 min Don’t miss out – Register Now: https://lnkd.in/dqTHKRmN #PharmaLex #Webinar #TMFExcellence #DocumentProcessing #ClinicalResearch Rob Jones Jacqueline Petty Sebastian Ogórek
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We can help you navigate the regulatory complexities of combination products. While these products offer significant therapeutic benefits, they also introduce additional layers of regulatory challenges. They require harmonized regulatory strategies and meticulous alignment of manufacturing processes to meet diverse compliance standards. Are you confident in your product’s classification and regulatory approval strategy? Discover how PharmaLex can help you confidently navigate dual regulatory pathways across multiple jurisdictions. https://lnkd.in/gpVm8W2 #PharmaLex #CombinationProducts #DeviceLedCombinationProduct #RegulatoryAffairs
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Unlock the full potential of your Contamination Control Strategy (CCS) with insights from Noelle Clifford's latest article! Discover essential strategies for overcoming common hurdles, including: 🌟 The importance of a proactive Quality Risk Management (QRM) approach. 🌟 Steps to develop a comprehensive and centralized CCS. 🌟 The critical role of cross-functional teams and expert involvement. 🌟 Utilizing quantitative methodologies like FMEA for robust risk assessments. 🌟 Adhering to EU GMP Annex 1 to ensure product quality and safety. Read full article here: https://lnkd.in/dXCUMfBk #PharmaLex #ContaminationControl #QualityRiskManagement #GMPCompliance #Annex1 #QualityControl
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Streamlining regulatory processes globally is essential for timely access to medical innovations 🌍🧬 In her latest article, "Alleviating the Regulatory Burden Through the Access Consortium," Piety Rocha discusses how simultaneous assessment and approval timelines across borders can benefit the pharmaceutical industry. Discover how regulatory authorities are evolving to meet these needs. Read full article here: https://lnkd.in/da95jkeq #PharmaLex #RegulatoryAffairs #AccessConsortium #PharmaceuticalIndustry #MedicalDevices #DrugApproval
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🚨 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
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Discover the groundbreaking role of strategic partnerships, global talent, and technological advancements in shaping the future of pharmaceutical R&D and commercialization. Learn more in a new blog post from Kirsten Jacobs, PhD, Chief Strategy Officer at PharmaLex: https://lnkd.in/dS-Qs_gc #PharmaLex #PharmaInnovation #BiotechRevolution #Technology
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⏰ Last Chance! ⏰ Registration is closing soon for our CTR Ask The Experts live webinar! Don’t miss your chance to pose your #ClinicalTrialRegulation (CTR) questions to our panel of experts during the live session. 🔔 Secure your spot now: https://lnkd.in/dhHqXHmy Xandra Neuberger Dr. Carolin Gloger Dr. Berit Bachmann, M.D.R.A. #PharmaLex #Webinar #RegulatoryCompliance
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