Pharma IT

🎓 As the end of the year approaches, it’s the perfect time to invest in your professional growth and start 2024 even stronger 💪 Upgrade your skills by joining one of Pharma IT Academy’s top-rated trainings! 📅 Upcoming Courses: - [Sold out] Clinical Development and Applied Good Clinical Practice (GCP) - Computer Systems Validation (CSV) & GAMP5 Basics - Good Manufacturing Practice (GMP) Basics - [Few spots left] NIS2 & Cybersecurity in Life Science - GDPR & Data Privacy in Life Science Sign up here -> 🔗 https://lnkd.in/dDpnny43 #PharmaITAcademy #Training #ProfessionalDevelopment #CSV #GMP #GCP #nis2 #gdpr #LifeSciences #gxp

🌱 We’re excited to share a key highlight from our Sustainability Report 2023! According to the latest APV Survey, Pharma IT's Work-Life Balance Satisfaction Rate has reached 88%. ⚖️ We strive to maintain at least 80%, which reflects our ongoing commitment to creating a workplace where our employees can maintain a healthy balance between their work and personal lives 💪 We’re proud of this progress and will keep striving to make work-life balance a priority for everyone For more information, check out our Pharma IT Sustainability Report 2023 here 🔗 https://lnkd.in/dPmnKQJ4

🎓 Last week, we had a fantastic group of participants dive into the world of GAMP 5 and Computer Systems Validation (CSV)! 🎉 Over two days, our attendees engaged in dynamic discussions and hands-on exercises, equipping themselves with essential knowledge and skills in GAMP 5 and CSV. Under the expert guidance of our instructors, Pia Nøhr Ellegaard and Dorte Juul, participants covered CSV essentials, including life cycle phases and the V-model, utilizing real-world examples from their extensive industry experience. On top of that, each participant walked away with invaluable CSV templates to enhance their own validation processes. A huge congratulations to all participants for completing the training! 🎓 Interested in joining our next GAMP 5 and Computer Systems Validation (CSV) training? Sign up here: 🔗 https://lnkd.in/eJyhFVWP

💡In the latest installment of our automation & AI in pharma series, we share an additional use case automation in a highly regulated reality. With the ongoing migration from the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD) to the Product Management Service (PMS), companies face the added challenge of ensuring seamless data integration and synchronization. 🔧 In this Insight, we delve deeper into the challenges of meeting these regulatory demands and present an automated IDMP Gap Analysis Tool solution to solve them. 🔗 Check it out: https://lnkd.in/e9Hcinhj

🎓 We’re excited to celebrate the kickoff of the fall season at Pharma IT Academy with the successful completion of our Good Manufacturing Practice (GMP) Basics training last week! 🎉 Over two engaging days, participants delved into insightful discussions and hands-on exercises, gaining valuable knowledge and practical skills in GMP 💪 Our expert instructors, Torben Elhauge and Pernille Zenia Bülow, guided the way, helping participants: • Understand GMP pharmaceutical quality systems and key terminology • Learn common concepts and methods of qualification and validation • Identify and describe relevant regulatory requirements concerning personnel, premises, equipment, documentation, and production • Recognize how GMP concepts apply in the daily work of life science professionals 🔗 Secure your spot and sign up for our next GMP Training on November 13-14 here https://lnkd.in/e2dKZqWa

Greetings from the Nordic Life Science Days! 🌟   Our Director of Regulatory Affairs, Anne Louise Kirkegaard, and Business Development Manager, Lars Bak-Christensen, are here and ready to connect!   💌 Contact us if you'd like to meet or swing by and say hello.   We can't wait to meet you! 👋 #NLSDays

🎉 We are excited to announce that we are once again a platinum sponsor for Nordic Pharmacovigilance Day 2024 in Copenhagen! Looking forward to connecting with you there! Our Drug Safety & Pharmacovigilance and Veeva Services Teams, led by Maria Skou Andersen and Sukhjit Gill, will be on-site and ready to meet you. 🗓 For more details about the event, click the link below 🔗 https://lnkd.in/dxXP_NgN

👋 Meet Mukhtar Yaqub, Principal Consultant at Pharma IT! With 16+ years of experience in the pharmaceutical industry and IT, Mukhtar specializes in IT service management, implementation, and transition projects. 💼 Recently, Mukhtar worked as system manager for MS Dynamics 365 Finance & Operations and as a project manager of a custom MS PowerApps solution tailored to the client's finance department. He also handled IT and Finance SOX reports and participated in external SOX audits, ensuring compliance with regulatory standards. 🎓 On top of that, Mukhtar is certified in Prince2 Foundation & Practitioner, ITIL, and has completed various Pharma courses such as GMP, CSV, GxP Life Cycle etc. 💡 Whether leading projects or consulting, Mukhtar bridges IT and business to ensure technology solutions align with broader goals, focusing on efficiency and regulatory compliance. His expertise also extends to fostering cross-functional collaboration to support organizational growth and innovation. Looking for support with project management, implementation or transition projects? Reach out to Peter-Emil Iversen today to explore how our team can help!

📢 The NIS2 Directive is the EU's updated cybersecurity directive aimed at strengthening the resilience of critical infrastructure sectors. Expanding on the original NIS, NIS2 comes into force this year and sets stricter security requirements and higher penalties for non-compliance, targeting industries such as Pharmaceuticals, Biotech, and Medical Devices.    Companies in these sectors must comply with enhanced cybersecurity measures, risk management protocols, and business continuity plans.   🎓At the Pharma IT Academy, we offer a tailored course for our industry: NIS2 & Cybersecurity in Life Sciences.    This hands-on training covers: ✅ Cybersecurity essentials and NIS2 principles ✅ Practical exercises on digital defense and vendor risk management ✅ Risk assessments and robust security protection strategies   🌐 🔐 Sign up today to prepare your team for NIS2 compliance 🔗 https://lnkd.in/diFYXDfu   📖 Want to learn more about NIS2? Check out the Pharma IT Insight on the directive, written by our expert instructor and Principal Consultant, Steen Lindebjerg 🔗 https://lnkd.in/ds3Qqk7j

🤝 Meet Mátyás Bódi, a Senior Consultant in Pharma IT's Commercial and Medical Consulting team! He brings over a decade of experience in the pharma industry, and is a specialist in implementing and optimizing CRM solutions. We sat down with him to hear about his experience in the industry and thoughts on the challenges currently facing Commercial Teams in the life sciences ⤵️ 𝐇𝐨𝐰 𝐝𝐢𝐝 𝐲𝐨𝐮 𝐠𝐞𝐭 𝐬𝐭𝐚𝐫𝐭𝐞𝐝 𝐢𝐧 𝐭𝐡𝐞 𝐜𝐨𝐦𝐦𝐞𝐫𝐜𝐢𝐚𝐥 𝐬𝐩𝐚𝐜𝐞 𝐰𝐢𝐭𝐡𝐢𝐧 𝐥𝐢𝐟𝐞 𝐬𝐜𝐢𝐞𝐧𝐜𝐞𝐬? I got my first taste of working in the commercial area in the pharma industry in 2015, when I started as a Product Support Engineer & Consultant at Veeva Systems. At the time, Veeva was still celebrating their recent IPO and the entire Budapest office fit into one big room. By the time I left 4 years later, Veeva was becoming a market leader. Looking back, it was an invaluable place to start my career because I gained a deep understanding of the complexity of life science commercial processes and how customers can best use their CRM systems to meet their needs. 𝐖𝐡𝐚𝐭 𝐜𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞𝐬 𝐝𝐨 𝐲𝐨𝐮 𝐬𝐞𝐞 𝐜𝐮𝐬𝐭𝐨𝐦𝐞𝐫𝐬 𝐟𝐚𝐜𝐢𝐧𝐠? I think its is still difficult to convince some leaders to move their processes and documentation into the industry cloud. Pharma is a tough industry and the competition is brutal, so medical and salespeople as well as IT professionals are working under pressure. At the same time, new technologies like AI are pushing the agenda forward at an extremely fast pace. 𝐂𝐨𝐮𝐥𝐝 𝐲𝐨𝐮 𝐬𝐡𝐚𝐫𝐞 𝐬𝐨𝐦𝐞 𝐢𝐧𝐬𝐢𝐠𝐡𝐭𝐬 𝐢𝐧𝐭𝐨 𝐭𝐡𝐞 𝐩𝐫𝐨𝐣𝐞𝐜𝐭𝐬 𝐲𝐨𝐮 𝐚𝐫𝐞 𝐢𝐧𝐯𝐨𝐥𝐯𝐞𝐝 𝐰𝐢𝐭𝐡 𝐫𝐢𝐠𝐡𝐭 𝐧𝐨𝐰? This year, I led an implementation project on Order and Sample Management. The client wanted to harmonize their business processes, while implementing a robust upgrade to their pricing engine. The whole environment was also integrated into a ERP system. Because of my previous experience, I was able to advise not just on technology and CRM, but on a much wider horizon. This included project management, communication, and knowledge transfer. At the end of the day, my goal is to help my client get the maximum use of their CRM system. 𝐈𝐟 𝐲𝐨𝐮 𝐧𝐞𝐞𝐝 𝐬𝐮𝐩𝐩𝐨𝐫𝐭 𝐰𝐢𝐭𝐡 𝐲𝐨𝐮𝐫 𝐂𝐑𝐌? 𝐂𝐨𝐧𝐧𝐞𝐜𝐭 𝐰𝐢𝐭𝐡 Mátyás Bódi 𝐭𝐨𝐝𝐚𝐲 𝐭𝐨 𝐞𝐱𝐩𝐥𝐨𝐫𝐞 𝐡𝐨𝐰 𝐡𝐞 𝐜𝐚𝐧 𝐡𝐞𝐥𝐩 💌