MAIN5

✴️ Driving the Future of Pharmaceutical Data: MAIN5 & Michiel Stam on IDMP Readiness How prepared is the pharmaceutical industry to fully embrace IDMP standards and the FAIR data principles that underpin modern digital transformation? Michiel Stam, Senior Regulatory Expert at MAIN5, explores this critical question in his latest article with Cell & Gene: “Survey Findings: How Are IDMP Readiness Efforts Progressing?” MAIN5, in collaboration with Pistoia Alliance and Accurids, conducted benchmark research to uncover where the industry stands in integrating IDMP across functions, and the results are both insightful and inspiring: ✅ 71% of companies recognize IDMP’s transformative potential for cross-functional data integration, yet challenges persist around data silos and ownership. ✅ Early adopters see Pistoia Alliance's IDMP-Ontology as the path forward to standardize and align data for regulatory, manufacturing, and supply chain integration. ✅ The survey reveals an optimistic momentum for using IDMP as the foundation for enterprise-wide digitalization, paving the way for better compliance, decision-making, and innovation. Michiel highlights that reigniting momentum around IDMP projects is essential, especially as regulatory frameworks like European Medicines Agency's Product Lifecycle Management portal take shape. His article offers actionable insights into how life sciences companies can strategically align resources, systems, and talent to make IDMP compliance—and the broader benefits it unlocks—a reality. 🧾 Read the full article here: https://lnkd.in/dSVv-Wht At MAIN5, we are proud to have experts like Michiel leading the charge to enable digitally-enabled change across life sciences R&D. This work doesn’t just advance regulatory frameworks—it contributes to a future where healthcare innovation thrives and patients worldwide benefit. #DigitalTransformation #IDMP #FAIRData #PharmaInnovation #MAIN5 #ThoughtLeadership #Regulatory #IDMPOntology

✴️ We are thrilled to announce that MAIN5 will be participating in the DIA Regulatory Submissions, Information, and Document Management (RSIDM) Forum from February 3-5, 2025 at the Bethesda North Marriott Hotel and Conference Center. 👋 As exhibitors, we invite all attendees to visit our booth and engage with our team of experts. Join Tore Bergsteiner, Matthias Sijtstra, Dominik Gigli, and Marjeta Panjan Žalec and discuss the latest trends, innovations and best practices in regulatory submissions, information, and document management. 🌟 Come talk to us and discover how MAIN5 can help you achieve regulatory excellence! Let's meet at #DIA #RSIDM 2025!

🌟 We are delighted to welcome Nerea González Sola to the MAIN5 team!  With over 3 years of experience in the pharmaceutical and life sciences sectors, Nerea brings a strong analytical and goal-oriented mindset, specializing in scientific environments and complex data-driven projects. Her expertise in data collection, cleansing, and visualization, along with her background in R&D and QA, ensure high-quality outcomes tailored to our clients’ needs. Nerea's ability to optimize workflows and collaborate across dynamic environments will be a tremendous asset to MAIN5. We look forward to working with her and benefiting from her precision and innovative approach to problem solving. 🤝 Welcome aboard, Nerea! 💼 Are you a seasoned professional looking for new challenges and want to make a significant impact within the Life Sciences industry?  Then check out our latest job offerings to join us in 2025 and become part of our journey towards excellence! https://lnkd.in/dMUMc_ZE

🌟 All we want for Christmas is You! Join MAIN5 as an Invoicing Specialist / Finance Specialist! 🌟 Ready to take your finance career to the next level? At MAIN5, we’re looking for a seasoned professional to: 🔸Execute monthly invoicing, drive invoicing accuracy and claims management. 🔸Optimize financial processes and time-recording systems (ZEP). 🔸Deliver internal training and support fleet/travel management. This is you: ✅ 8+ years of experience in accounting/receivables (DATEV knowledge is a plus). ✅ Expertise in process optimization and automation. ✅ Fluent German and English with strong communication skills. ✅ Hands-on, detail-oriented, and flexible mindset. Why MAIN5? ✨ Exciting projects, international clients, and a supportive team. ✨ Flexible hours, remote work, and above-average earnings. ✨ Long-term growth, training opportunities, and a creative work culture. 📩 Apply now and grow with us! If you're an entrepreneurial spirit ready to take on new challenges and make a significant impact, we want to hear from you! Join us in shaping the future of MAIN5 and be a part of our journey towards excellence!   You will find further details on our company website under: https://lnkd.in/dMUMc_ZE

✴️ Survey Insights: Progress in IDMP Readiness  Our latest survey, conducted with Pistoia Alliance and Accurids, reveals significant strides and challenges in #IDMP #readiness across the life sciences industry. Key Highlights:  🔸 70% of large pharma companies see IDMP as crucial for data integration.  🔸 Manual data collection and silos remain major hurdles.  🔸 The IDMP-O project by Pistoia Alliance shows promise, with 43% ready to implement it within a year. Recent advancements, like the European Medicines Agency's Product Lifecycle Management portal, are reigniting momentum. Companies must now define strategic steps and train their workforce to meet IDMP requirements efficiently. 🧾 For an in-depth analysis, read the full article "Survey Findings: How Are IDMP Readiness Efforts Progressing?" by Michiel Stam, Senior Regulatory Expert at MAIN5, at Pharmaceutical Online: https://lnkd.in/dTnjn44b #IDMP #Pharma #DigitalTransformation #DataManagement #MAIN5 #IDMPOntology #Accurids

✴️ Realizing the Benefits of IDMP: Key Challenges Facing the Industry 💡 The majority—89%—of pharma companies recognize the long-term value of IDMP in their digitalization strategies. However, significant challenges remain, including: 🔸 a lack of standardization, 🔸 insufficient resources,  🔸 unclear data ownership,  🔸 and data quality issues.  These challenges hinder progress towards effective data integration and continue to be the major barriers toward delivering efficiency improvements. 🌟 These insights come from a new industry benchmark survey conducted by MAIN5, Accurids and the Pistoia Alliance’s IDMP-Ontology (IDMP-O) project team. The IDMP-O project aims to create a shared ontology aligned with #ISO #IDMP standards, providing a standardized framework and collaborative platform to ensure consistent adoption of IDMP. 📑 To see how your company's progress compares to industry peers, download your complimentary copy of the full benchmark report, "Accelerating Digital Transformation in Pharma with IDMP: An industry benchmark report on the status of IDMP standards implementation in Pharma and the role of the IDMP Ontology for accelerating digital transformation", here: https://lnkd.in/dMHEYVjK

🌟 Reflecting on the success of the 6th Quality Management System User Group Meeting Day (QMS Day) 2024 🌟 What an incredible day it was! The 6th QMS Day brought together industry leaders and experts from the Life Sciences sector for an exclusive exchange on best practices, challenges, and innovations in Quality Management Systems. We were thrilled to see such engaged participation, with insightful presentations, and vibrant discussions, exploring current issues, market trends, future challenges, and potential solutions. A heartfelt thank you to all attendees for their active participation, sharing valuable insights, and contributing to the dynamic conversations that made this day so impactful. 🤝 A special thank you goes out to PARI, the host of this year’s event, for providing a wonderful location and ensuring a seamless and inspiring environment for our meeting. Your dedication to excellence set the perfect stage for meaningful exchanges. We extend our thanks to our speakers Ralf Markthaler from PARI, Patrick O’Sulivan from BI and Tanja Smolić Bumber, Verena Jachmann, and Annette Prelle from MAIN5 for their insightful presentations and contributions to our discussions. As we reflect on the success of this year’s event, we’re already looking forward to the next QMS Day and continuing to foster collaboration and innovation in our industry. 📧 If you're interested in joining our Quality Management Community or participating in our Quality Management User Group Meeting, please feel free to reach via contact@main5.de. Your involvement is vital to our collective progress. #MAIN5 #QMSDay2024 #LifeSciences #QualityManagement #BestPractices #Innovation #Collaboration

✴️ Last Week, MAIN5’s experts Marko Lubura, Jens Marburg and Managing Partner Alexander T. had the privilege to attend the 17th GAMP D-A-CH Conference. With over 140 participants, the event proved to be an outstanding platform for exchanging ideas, fostering collaboration, and networking within the #Quality and #Compliance community. Held on the 3rd and 4th of December, the conference brought together GxP Quality and CSV Compliance enthusiasts, thought leaders, and industry authority representatives to discuss key topics and share experiences that will influence the future of the life sciences sector. Among the many compelling presentations, we’d like to highlight: 🔶 Yves Samson’s talk on “Von Daten zum Produkt”, which delivered valuable insights into the Pharma Product Lifecycle—from data to the final product. 🔶 Sascha Howey’s presentation on “Cybersicherheitsrisiken und Resilienz: Wie wappne ich mich für den Ernstfall”, which shed light on cybersecurity risks, regulatory expectations, and unique challenges within the Life Sciences industry. These sessions, along with the vibrant discussions they inspired, underscored the importance of ongoing dialogue and innovation in navigating challenges and opportunities in the industry. Looking forward, we’re excited about the future of the GAMP D-A-CH series. #MAIN5 is proud to announce that we’ll be actively participating in the upcoming GAMP D-A-CH Forums in March and September, as well as next year’s GAMP D-A-CH Conference. Our experts are eager to contribute to these discussions, helping shape the future of the Life Sciences industry. 🌟 Let’s continue to drive excellence in #Quality, #Validation, and #Compliance!

🌟 MAIN5 at the 2024 #TOPRA #Awards for #RegulatoryExcellence 🌟 Last week, MAIN5 had the privilege of participating in the prestigious TOPRA Awards for Regulatory Excellence as a proud sponsor of the Contribution category. This annual event celebrates the outstanding achievements of individuals and organizations shaping the regulatory landscape, and it was an honor to be part of this inspiring evening. 🏆 Our Managing Partner, Tore Bergsteiner, presented the Contribution Award to the remarkable Michelle Blake, recognizing her significant impact on the field of regulatory affairs. Congratulations, Michelle—your work exemplifies the innovation and dedication that drive our industry forward! 🤝 The night was made even more special by the presence of our esteemed guests: our partner ArisGlobal being represented by Aman Wasan, CEO, and Salil Jamwal, VP, Digital Transformation & Strategic Partnerships, as well as Jack Daley, Director, Regulatory Operations at Organon and Ian Crone, VP Global Strategic Solutions at our partner fme AG. Together, we shared not only in celebrating the winners but also in engaging in meaningful conversations about the future of regulatory affairs. At MAIN5, we believe that regulatory excellence is a collective effort, and we are proud to collaborate with incredible partners and support initiatives that highlight the outstanding contributions within our industry. 🧡 A huge thank you to TOPRA for organizing such a memorable event and to all the finalists and winners for their dedication and leadership in shaping the future of regulatory affairs. Here’s to continued collaboration, innovation, and success in 2025 and beyond! #TOPRAAwards #RegulatoryExcellence #MAIN5 #Partnerships #DigitalInnovation #LifeSciences #Innovation #Regulatory #RegulatoryAffairs

✴️ MAIN5 is proud to be part of the 17th GAMP D-A-CH Conference in Mannheim, where thought leaders and industry experts are coming together to explore the evolving landscape of GxP compliance and innovation. Our experts - Marko Lubura, Jens Marburg, and Managing Partner Alexander T. - are actively engaging in discussions, attending insightful presentations, and exchanging ideas with the vibrant #GAMP community. ⭐ One highlight so far has been Yves Samson's dynamic presentation, which offered valuable insights into the Pharma Product Lifecycle, from data to product (“Von Daten zum Produkt”). 📑 MAIN5 is also excited to facilitate the Life Sciences Digital Survey, launched exclusively at this conference. This initiative invites attendees to share their priorities, challenges, and perspectives, fostering a deeper understanding of the key considerations and potential pitfalls within the community. We encourage all attendees to participate and help shape the future of GxP compliance and innovation. 👋 If you’re at the conference, don’t hesitate to connect with our team - we’d love to engage in meaningful conversations and explore opportunities to collaborate. Here’s to an inspiring event and the collective drive for innovation in Life Sciences! #GAMP #GAMPDACH #ISPE #VDI #ISPEDACH #lifesciences #Validation #CSV #GxP #GAMPROCKS