PharmaLex

Explore our global events this week 🌍 Join us as we focus on the European market with exciting events in Ireland and Norway! 🔹 PDA Ireland Chapter: Microbiology Event | February 27, 2025 | Cork, Ireland 🎙️ Attendees: Patrick Nieuwenhuizen, Ann-Marie Purcell, Louise Uí Fhatharta & Elizabeth Hunt 🔗 Register here: https://lnkd.in/dJm9fNAj 🔹 Brain & Breakfast Norway | February 27, 2025 | Oslo, Norway 🎙️ Attendees: Herbert Altmann, Nina Andersson, Hege Rønning & Saila Schönberg 🔗 Register here: https://lnkd.in/dhybSFZ8 Join us to gain insights from industry experts and expand your professional network! #PharmaLexInTheField #Pharma #Networking #Events #GlobalExpertis

🔥 TMF on fire before an inspection? Call our TMF Fire Brigade for help! Contact Us Now: https://lnkd.in/dWHePFR For many reasons organizations may not be prepared for an inspection leading to higher risks of non-compliance, negative findings, and potential fines. But fear not— we’re here to help you navigate the challenging process of TMF inspection- readiness. Check out this insightful guide on surviving a TMF inspection when you’re not ready for one: https://lnkd.in/dh7mdEcw #TMF #ClinicalTrials #InspectionReadiness #RegulatoryCompliance #RiskManagement #ClinicalDocumentation #QualityAssurance #RegulatoryAffairs #ClinicalTechnology

Discover how PharmaLex transformed a mid-sized biopharmaceutical company's local PV processes across 94 countries! 🌍 By implementing a new Oracle Argus LAM Hub model and leveraging our extensive network of local PV experts, we achieved: ✅ Improved cross-functional communication ✅ Standardized ICSR processing ✅ Enhanced compliance tracking ✅ Streamlined training platforms The result? Significant improvements in quality, efficiency, and cost control. Read the full case study: https://lnkd.in/dQeYFNVi #Pharmacovigilance #Innovation #Efficiency

Join our webinar this Thursday, February 27th! Hear from our experts as they share real-world examples of how #biopharma companies are successfully navigating complex regional and local pharmacovigilance requirements. Discover strategies to enhance patient safety, reduce risk, and optimize growth. Register today: https://lnkd.in/dKN_eGNj

Dive into our latest article by Cori Gorman, Ph.D., to explore how #AI and digital technologies are transforming Chemistry, Manufacturing, and Controls (#CMC) in the biopharma industry. From regulatory trends to supply chain optimization, learn how these innovations are paving the way for a more efficient, compliant, and resilient future. Read the full article: https://lnkd.in/dpnNWjVS #PharmaInnovation #DigitalTransformation #Biopharma

Meet Petra Kalmar, our Director of Regulatory Affairs, CMC! 🎤 𝗪𝗵𝗮𝘁 𝗶𝘀 𝘆𝗼𝘂𝗿 𝗿𝗼𝗹𝗲 𝗮𝘁 𝗣𝗵𝗮𝗿𝗺𝗮𝗟𝗲𝘅? As the Director Regulatory Affairs CMC, I support our clients in development, manufacturing, and control. My broad experience in the pharmaceutical industry, my knowledge of the regulatory framework and my understanding of GMP and manufacturing also enable me to develop smart CMC strategies that fit well into the overall concept of our clients' regulatory strategies. Advising clients is a key part of my role. I also contribute to the global CMC management team and work on developing our local CMC expert team. 🎤 𝗛𝗼𝘄 𝗱𝗼 𝘆𝗼𝘂 𝗮𝗽𝗽𝗿𝗼𝗮𝗰𝗵 𝘀𝘁𝗮𝘆𝗶𝗻𝗴 𝗮𝗵𝗲𝗮𝗱 𝗼𝗳 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝘆 𝘁𝗿𝗲𝗻𝗱𝘀 𝗮𝗻𝗱 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻𝘀 𝗶𝗻 𝘆𝗼𝘂𝗿 𝗳𝗶𝗲𝗹𝗱? Staying updates with the legal framework and to work closely with my team to identify new requirements or changes to existing legislation and analyse their impact. It is essential to make optimum use of various resources, such as websites of authorities and associations, but also my personal network. My openness and flexibility in my working style help me to develop new ideas for the implementation of changes that also fulfil revised or new regulatory requirements. In general, we at PharmaLex endeavour not only to keep pace, but also to set the direction for new developments and trends. In this way, we can always offer our clients up-to-date solutions. 🎤 𝗪𝗵𝗮𝘁 𝗶𝗺𝗽𝗮𝗰𝘁 𝗱𝗼 𝘆𝗼𝘂 𝗵𝗼𝗽𝗲 𝘁𝗼 𝗺𝗮𝗸𝗲 𝘁𝗵𝗿𝗼𝘂𝗴𝗵 𝘆𝗼𝘂𝗿 𝘄𝗼𝗿𝗸 𝗮𝘁 𝗣𝗵𝗮𝗿𝗺𝗮𝗟𝗲𝘅? With my work, I would like to contribute to strengthening the pharmaceutical industry and research in Europe, especially in the DACH region, and thus also ensure the global security of supply of medicines in the future. While we, as consultants, support our clients operationally by taking on lifecycle activities that can be planned for the long term, or also very flexibly handling short-term enquiries, the companies can concentrate on their strengths, such as the development and manufacture of innovative and safe products. 🎤 𝗖𝗮𝗻 𝘆𝗼𝘂 𝘀𝗵𝗮𝗿𝗲 𝗮 𝘀𝘁𝗼𝗿𝘆 𝗮𝗯𝗼𝘂𝘁 𝗮 𝗺𝗲𝗻𝘁𝗼𝗿 𝗼𝗿 𝗰𝗼𝗹𝗹𝗲𝗮𝗴𝘂𝗲 𝘄𝗵𝗼 𝗵𝗮𝘀 𝘀𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁𝗹𝘆 𝗶𝗻𝗳𝗹𝘂𝗲𝗻𝗰𝗲𝗱 𝘆𝗼𝘂𝗿 𝗰𝗮𝗿𝗲𝗲𝗿? For many years, I worked with a line manager who recognised my strengths and interests right at the start of my career and always gave me the opportunity to develop my skills and realise my full potential. It was a win-win situation for everyone. I always enjoyed my work, was able to continuously develop my knowledge, pass on the expertise to the team and thus contribute to the company's success. My enthusiasm for CMC is still there today and I would like to be a role model for other CMC professionals as well. Learn more about our Regulatory Affairs and CMC solutions: https://lnkd.in/ePaZ3HgH #TeamSpotlight #CMC

📢 𝐅𝐢𝐧𝐚𝐥 𝐜𝐡𝐚𝐧𝐜𝐞 𝐭𝐨 𝐫𝐞𝐠𝐢𝐬𝐭𝐞𝐫: 𝐄𝐔 𝐇𝐓𝐀 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧 𝐞𝐯𝐞𝐧𝐭 𝐭𝐡𝐢𝐬 𝐓𝐡𝐮𝐫𝐬𝐝𝐚𝐲 On February 27, industry experts will gather at Forskningsparken - Oslo Science Park for an in-depth discussion on the EU Health Technology Assessment (HTA) regulation - a key shift impacting market access, innovation, and patient care across Europe. We are pleased to welcome Matias Olsen, Senior Manager, Public Affairs & Policy at EUCOPE - European Confederation of Pharmaceutical Entrepreneurs, who brings extensive expertise in EU HTA implementation, advanced diagnostics, real-world evidence, and market access strategies. Matias will provide valuable perspectives on how companies can navigate and prepare for the evolving regulatory landscape. Matias will join Herbert Altmann, an expert in EU market access, who will discuss strategic considerations for Norwegian companies under the new framework. 📅 Thursday, February 27 | 08:30 - 10:00 📍 Forskningsparken - Oslo Science Park 🔗 Register now: https://lnkd.in/dYtYs364 PharmaLex | Saila Schönberg | Hege Rønning | Nina Andersson | Delphine Costa | Hanne Mette Kristensen | Benjamin Dyhre

Enhance Your Pharmacovigilance Outsourcing 🌍 Our Best Practice Guide offers #biopharma companies expert advice on managing local affiliate PV across diverse markets. Swipe through our carousel to explore the best practices for effective outsourced local affiliate #pharmacovigilance: ➡️ Position affiliate partners for success ➡️ Create clear communication channels ➡️ Establish robust oversight mechanisms ➡️ Understand local circumstances ➡️ Maintain key relationships ➡️ Harness technology innovations Download Now: https://lnkd.in/ddZKJfDp

Discover how the UK's International Recognition Procedure (#IRP) is revolutionizing the pharmaceutical landscape post-Brexit. Authored by our experts, Aashni Shah and Dr Claire Stevenson this article delves into the IRP's impact on #regulatory processes, highlighting its benefits for faster #marketaccess and international collaboration. Key Highlights: • Streamlined Assessments: How the IRP leverages decisions from trusted global regulatory partners. • Expedited Approvals: Faster review times with Recognition Pathways A and B. • Lifecycle Management: Post-approval submissions and variations made easier. Read the full article: https://lnkd.in/g6zF68Zz #Compliance #Pharma #Regulations #Innovation

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