MAIN5

🌟 EMA PMS Compliance – A Future-Proof Solution by MAIN5 & Accurids ❗Regulatory complexity is rising, and manual processes are no longer sustainable. With IDMP compliance deadlines approaching, pharmaceutical companies face increasing pressure to ensure data integrity, efficiency, and compliance with evolving EMA requirements. For an in-depth understanding of EMA PMS requirements, download our comprehensive white paper: https://lnkd.in/dCmEgkt9 🤝 MAIN5 and Accurids have partnered to offer a #scalable, #automated solution that enables seamless data standardization, centralization, and compliance with ISO IDMP.

✴️ Industry Outlook 2025: Looking at the Mega Trends MAIN5's Managing Partner, Tore Bergsteiner, recently engaged in an illuminating discussion with Felicity Thomas, MChem from Pharmaceutical Technology®, delving into the pivotal trends set to shape the pharma industry in 2025 and beyond. 🗝️ Key Highlights from the Interview: 🔸Artificial Intelligence (AI): Tore emphasizes that AI is "already reshaping a variety of key processes in pharma," underscoring its growing significance in daily operations and industry competitiveness. 🔸Supply Chain Globalization: The discussion touches on the importance of diversifying efforts to reduce dependency on single regions for API and manufacturing needs. 🔸Regulatory Reforms: Insights into how streamlined pathways in the US and EU are fostering innovation, particularly in rare diseases and oncology, and the push for digitizing end-to-end processes to remain competitive and compliant. 📽️ Watch the Full Interview: https://lnkd.in/eMwV4xe6 ❔What are your predictions for the pharma industry in 2025? ❔How do you envision AI and digital transformation influencing our field? #PharmaIndustry #DigitalTransformation #AI #SupplyChain #Regulatory #MAIN5 #PharmaTrends2025 #PharmaTech

✴️ EMA PMS Compliance: Burden or Strategic Opportunity? By 2026, IDMP compliance will become significantly more complex for pharmaceutical companies operating in the EU. The EMA Product Management Services (PMS) Requirements are not just another regulatory hurdle—they represent a strategic opportunity to enhance efficiency, streamline compliance, and gain a competitive advantage. In collaboration with our partner Accurids, MAIN5 has created a comprehensive white paper: 📖 "Navigating EMA PMS Requirements: A Strategic Guide for Regulatory Leaders" https://lnkd.in/dCmEgkt9 This guide provides actionable insights for regulatory professionals to: ✅ Align with IDMP standards and streamline regulatory submissions ✅ Improve data accuracy for efficient communication with authorities ✅ Enhance product lifecycle management for faster approvals and market access Who should read this? ✔ Regulatory Affairs & Compliance Leaders – Ensuring alignment with EMA PMS requirements ✔ Regulatory Operations Teams – Managing data standardization and submission processes ✔ IT & Digital Transformation Leaders – Implementing PMS-compliant infrastructures ✔ Quality & Pharmacovigilance Experts – Enhancing data accuracy and patient safety 📩 Download the white paper now and become PMS ready! https://lnkd.in/dCmEgkt9 #Accurids #MAIN5 #EMA #compliance #LifeSciences

❗The Problem: Keeping internal data aligned with EMA PMS   The European Medicines Agency’s stricter data requirements are putting significant pressure on pharmaceutical companies, challenging their resources and compliance capabilities. Fragmented data silos and reliance on manual processes further exacerbate these challenges, leading to inefficiencies, increased costs, and heightened risks of non-compliance. ✴️ The Opportunity: EMA PMS   Regulatory complexity is increasing, and manual processes are no longer sustainable. Pharma companies must transition to a data-driven, automated compliance approach to stay ahead. A centralized, structured system ensures data integrity, reduces compliance risks, and frees up resources for strategic initiatives. 💡 With the right technology and expertise, organizations can turn regulatory challenges into opportunities for efficiency, innovation, and competitive advantage. 🌟 The Solution: EMA PMS Compliance with a Turnkey Solution for Pharma!   https://lnkd.in/d46sGfun MAIN5 and Accurids solve your challenges! We offer a standards-based out-of-the-box solution with unmatched expertise and technology!  ✅ Automated Data alignment   ✅ Real-time Compliance Updates   ✅ IDMP Ontology based model   ✅ Seamless System Integration  ❔ Do you want to become PMS ready?  🚀 Then let us transform #Compliance into #Opportunities!  https://lnkd.in/d46sGfun  📧 Reach out at sales5@main5.de and meet with Accurids' and MAIN5’s experts to discuss shaping the Future of Medicinal Product Management!  🌐 Find out more about our EMA PMS Compliance here: https://lnkd.in/d46sGfun

👋 Meet us at the Pistoia Alliance Conference! Marjeta Panjan Žalec, Dominik Gigli, and Karsten Krueger will be representing MAIN5 at the upcoming Pistoia Alliance Conference, held at Royal Society of Medicine. This two-day event promises to be a hub of innovation, featuring inspiring sessions, thought-provoking discussions, and unparalleled networking opportunities with global experts in the life sciences industry. At #MAIN5, we are dedicated to driving the future of life sciences through innovation, collaboration, and digital transformation. The Pistoia Alliance Conference is a key event where industry leaders unite to address shared challenges and accelerate advancements in biopharmaceuticals. If you're attending, let's connect! 📩 marjeta.zalec@main5.de 👋 See you in London!

💬“There have already been successes with AI-approaches seen in the field of personalized drugs. The human metabolism is so different between patients, but AI enables us to develop treatments tailored to individual genetic profiles, improving therapeutic efficiency, efficacy, [and] reducing adverse reactions.” 🌟 MAIN5's Managing Partner, Tore Bergsteiner, shares Insights on 2025 Pharma Trends. In his interview with Felicity Thomas, MChem of Pharmaceutical Technology® Tore delves into the mega trends shaping our industry, emphasizing the critical role of digital transformation and data-driven strategies. Watch the full interview to gain a deeper understanding of these trends and their implications for the future. 🎥 https://lnkd.in/de9eTUwf ❔What are your predictions for the pharma industry in 2025? Share your thoughts in the comments below or reach out to us at contact@main5.de to continue the conversation. #Pharma2025 #DigitalTransformation #MAIN5 #PharmaceuticalTrends #IndustryInsights #LifeSciences

👋 We are at #DIAEurope2025! – Let’s Connect! We’re looking forward to an insightful final day of discussions, networking, and innovation! 📌 A Must-Attend Session: IDMP Data Harmonisation & Multi-Stakeholder Perspectives At 10:30 AM, Tore Bergsteiner and Lena Pauli will be attending this important session on IDMP Data Harmonisation, a key topic shaping the future of regulatory data management. 💡 Why Does This Matter? Standardized medicine data—aligned with ISO-IDMP and international standards—is essential for ensuring quality, safety, and efficacy across Europe's healthcare system. It enables seamless data exchange between industry, regulators, and healthcare professionals while driving digital transformation in the pharmaceutical sector. 💬 Let’s Continue the Conversation! Join Tore and Lena after the session for a coffee and discuss IDMP implementation, challenges, and best practices. 📍 Where to Find Us? Drop us a message or meet us right after the session! 📞 +49 151 111 747 08 📱 DIA App #DIAEurope2025 #IDMP #RegulatoryAffairs #DataHarmonisation #DigitalTransformation #PharmaInnovation #MAIN5 #Regulatory #Digitalization

🗨️ “[AI] will become a more and more relevant technique impacting our daily businesses, our overall competitiveness in the industry." Our Managing Partner, Tore Bergsteiner, recently sat down with Felicity Thomas, from Pharmaceutical Technology to discuss the trends shaping the pharmaceutical industry in 2025 and beyond. 📽️ Watch the whole interview here: https://lnkd.in/eMwV4xe6 His perspective aligns perfectly with the discussions happening right now at ArisGlobal Breakthrough 2025. While #AI and #GenAI promise groundbreaking advancements across the R&D IT ecosystem, organizations must move beyond buzzwords and prioritize use cases that drive meaningful change. At #AGBreakthrough25 keynotes, panels, and networking sessions showcase how industry pioneers are already seeing results from thoughtful AI implementation. Let’s explore how next-generation technologies can address essential business challenges and drive real impact. 📍Tore and the MAIN5 team are looking forward to engaging in discussions that will define the future of pharma. Visit our booth and learn how #MAIN5 can support your company's digital transformation. 🤝 Together, let's drive digital transformation in Life Sciences! See you at our booth!

👋 Come visit us at #AGBreakthrough25 Don't miss the chance to meet our experts! Visit our booth and engage with Christine Hirt, Nenad Čajko, and Sinisa Belina. Connect with Marjeta Panjan Žalec, Sarra Othmani, MBA, and Tore Bergsteiner to learn how #MAIN5 can support your company's digital transformation. 🤝 Together, let's drive digital transformation in Life Sciences! See you at our stand!

✴️ Meet us at the Pistoia Alliance Conference in London 🗓️ March 25 - 26, 2025 📍 Royal Society of Medicine, London MAIN5 is committed to shaping the future of life sciences by driving innovation, fostering collaboration, and advancing digital transformation. That’s why we’re excited to join the Pistoia Alliance Conference 2025 - a key event where industry leaders come together to solve shared challenges and accelerate progress in biopharmaceuticals. Join Marjeta Panjan Žalec, Dominik Gigli, and Karsten Krueger at the Royal Society of Medicine on March 25-26, 2025, for two days of inspiring sessions, thought-provoking discussions, and networking with global experts. If you're attending, let's connect! 📩 marjeta.zalec@main5.de Founded in 2008 by representatives form AstraZeneca, GSK, Novartis, and Pfizer, the Pistoia Alliance encompasses 200+ global members—from top pharma companies to CROs, tech providers, academia, and patient groups— all united by the vision that collaboration drives greater achievements.  Last year, MAIN5 and Accurids partnered with the Pistoia Alliance to conduct an industry benchmark survey on IDMP implementation in pharma, highlighting how the IDMP Ontology can accelerate digital transformation. We joined the Pistoia Alliance because we believe in the power of collaboration to drive innovation and improve R&D efficiencies in the life sciences industry. 🤝 Together, let's drive digital transformation in life sciences. 👋 See you in London!