PharmaLex

If you're in Sweden this week, don’t miss the opportunity to connect with Christine Mellborg and the World Courier team at ATMP Sweden! This premier annual conference brings together ATMP stakeholders from pre-clinical research to reimbursement and standard of care. 🔹 ATMP Sweden | November 25-26, 2024 | Malmö, Sweden 🔗 Register here: https://lnkd.in/gJEZFfKX Join us at the 5th physical annual conference featuring 60 speakers, both Swedish and international, 450 registrants, and 50 sponsors. #PharmaLexInTheField #Pharma #Networking #Events #GlobalExpertise

Elevate your Trial Master File (TMF) management with our expert team! 📑 As a part of Phlexglobal, a PharmaLex company now part of Cencora, we are a global authority in TMF best practices. Hundreds of sponsors and CRO companies worldwide trust our next-generation eTMF solution and 150+ experts to enhance TMF management and minimize inspection risk. We blend TMF expertise with innovation in everything we do. From industry leading TMF AI to expert quality review and embedded study owners, we help busy study teams achieve the highest standards for TMF completeness, timeliness, and quality. Learn more about our TMF Solutions here: https://lnkd.in/dgzhfXQY #Pharmalex #PharmalexSolutions #TMFSolutions #TMF #ClinicalTrials

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

Excited to share insights from the recent Pharmaceutical Information and Pharmacovigilance Association (#PIPA) conference in London! 🏥💊 This event highlighted the crucial role of #pharmacovigilance (PV) within the pharmaceutical industry, covering a wide range of topics from product acquisition management to personalized patient safety. Key highlights from the conference include: 🔹 The integration of PV in M&A activities 🔹 Insights and tips from MHRA inspections 🔹 Cardiac safety considerations in clinical trials 🔹 Development of personalized safety strategies Read full article here by Dora (.: https://lnkd.in/deeS7zwf Stay at the forefront of pharmacovigilance with #Pharmalex! #PatientSafety #PharmaIndustry

Navigate the regulatory landscape with confidence with our Regulatory Affairs expertise! 🚀 Our comprehensive Regulatory Affairs Services empower you to navigate regulations seamlessly. From pharmaceuticals to biologics and medical devices, our portfolio supports companies throughout the product lifecycle. Explore our Regulatory Affairs solutions here: https://lnkd.in/ePaZ3HgH #Pharmalex #PharmalexSolutions #RegulatoryAffairs #Compliance

NIBRT National Institute for Bioprocessing Research and Training recently hosted an event showcasing their new Filling and Isolator System for aseptic syringe filling. This innovation not only enhances training capabilities but also aligns with the latest EU GMP #Annex1 requirements. 💉🔬 NIBRT is shaping the future of #biopharmaceutical manufacturing. Check out our key takeaways from the event by Patrick Nieuwenhuizen and Noelle Clifford. Read full article here: https://lnkd.in/dYNW4pBn

Discover the Secrets of Managing CTR in Our On-Demand Webinar! Join seasoned professionals as they unravel the complexities of Clinical Trial Regulation (CTR) management. This on-demand roundtable offers invaluable insights and practical strategies to navigate this challenging landscape. 📅 Available Now ⏰ 1 Hour 📍 Your Desk! Watch now: https://lnkd.in/dNUrSMgH #PharmaLex #OnDemandWebinar #ClinicalTrials #CTR #PharmaceuticalIndustry #ClinicalDevelopment #CTIS Xandra Neuberger Dr. Carolin Gloger Dr. Berit Bachmann, M.D.R.A.

Globalization brings both opportunities and challenges for the pharmaceutical industry. Companies must stay agile and compliant amidst evolving regulations. This article by Dr. Stefanie Lietsch-Dallwig explores how to manage local and global regulatory requirements, ensuring quality and safety. It also highlights the benefits of outsourcing and partnerships to streamline processes and stay competitive. 🔗 https://lnkd.in/d_bajxVN Discover how to navigate these complexities and safeguard your products effectively. #PharmaLex #RegulatoryCompliance #Pharmaceuticals #Globalization #QualityAssurance

As countries tighten PV requirements, local affiliates face increasing demands. Alex Brenchat's latest article explores essential strategies for managing local PV activities effectively, focusing on people, platforms, and processes. Discover how to ensure continuous oversight, streamline operations, and integrate external resources seamlessly. Read the full article: https://lnkd.in/dJeVEGW3 #Pharmacovigilance #LocalAffiliates #BestPractices #PharmaIndustry #Compliance #GlobalHealth

Our very own Luis Dominguez Sanchez recently led an enlightening seminar at Universidad Carlos III de Madrid! 🎓✨ This hybrid session, part of the Science Management and Evaluation course, delved into the intricacies of scientific writing and the art of crafting successful funding proposals for Horizon Europe. With around 20 enthusiastic participants joining both online and in-person, it was a fantastic opportunity for knowledge sharing and professional growth! 🚀 #ScienceManagement #HorizonEurope #ScientificWriting #UC3M #ProfessionalDevelopment