Pharma IT

💡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've just wrapped up our last Good Manufacturing Practice (GMP) Basic training for 2024 at Pharma IT Academy! A big shoutout to our fantastic participants who just completed the training! 🎉 Over two days of engaging discussions and hands-on exercises, our participants immersed themselves in the world of GMP, gaining valuable insights and practical skills.💡 But don’t worry if you missed out—we’re kicking off the new year with another GMP Basics on 28-29 January 2025! If you want to level up your GMP knowledge and practical skills, you can sign up here 🔗 https://lnkd.in/eDbgKezi. Guided by our expert instructor Torben Elhauge, our training not only helps you master existing regulatory requirements but also sharpens your critical thinking to effectively apply GMP principles in your daily work. 💪 Join us to dive into Good Manufacturing Practice and see how it applies to your daily work in life sciences.

That's a wrap! Yesterday our Pharmacovigilance and Veeva Systems Services Teams attended Nordic Pharmacovigilance Day where we heard from fantastic speakers about ⤵️ 💻 Handling Safety Data from Digital Media 📈 Graph Theory in Pharmacovigilance 🧐 PV Supplier Oversight ☑️ Pre-Qualification of a PV Supplier 🇪🇺 🇺🇸 Post-Market Reporting for Drug-Device Combination Products in the EU versus US 🔎 Assessing and Enhancing the Effectiveness of Risk Minimisation Measures We had such a great time meeting so many of you! Feel free to reach out to our team at info@pharmait.dk Thank you to our speakers: Maria L. Murholm, Piotr Nowicki, MD, MBA, Jeanette Johansson, Henrik Bengtsson, Patricia Jiménez Vasquez, Juan Paolo Granada, Maj-Britt Schmidt Andersen, and Per Sindahl LS Academy #PHVDay

🎓 Last week at Pharma IT Academy, we were thrilled to welcome a fantastic group of participants for our GAMP 5 and Computer Systems Validation (CSV) Basics training! 🎉 Over two days, participants engaged in interactive discussions and hands-on exercises, gaining crucial skills in GAMP 5 principles and CSV best practices. Guided by our expert instructors, Pia Nøhr Ellegaard and Mike Astrup Nygaard, participants explored the full CSV life cycle, the V-model, and applied real-world examples drawn from the instructors’ extensive industry backgrounds. Each participant left with not only new insights and knowledge but also practical CSV templates to enhance their own validation processes. A huge congratulations to all for successfully completing the training! 👏 Sign up here for our next training, here: 🔗 https://lnkd.in/dDpnny43

Introducing Vasileios Papadopoulos, who joined Pharma IT’s Project Management team as a Principal Consultant at the beginning of October! 🎉 With a wealth of experience across the pharmaceutical, medical device, and bioscience industries, Vasileios brings a strong background in IT, engineering, quality production, and supply chain. He’s passionate about building high-performance teams that simplify complex challenges and deliver impactful solutions for clients. At Pharma IT, Vasileios will be focusing on implementing innovative IT and automation solutions for our clients. We asked Vasileios what drew him to Pharma IT, and here’s what he shared ⤵️ 💼 “Pharma IT’s focus on the pharmaceutical, biotech, and medical device industries is a perfect match for my experience. I’m impressed by the team’s deep understanding of industry challenges and their commitment to innovative solutions.” 🌐 “What excites me most about Pharma IT is its dedication to driving positive change and being part of a team of highly skilled professionals.” 🤝 “So far, I’ve been impressed by my teammates’ experience, agility, and their commitment to finding the best possible solutions for our clients.” Welcome to Pharma IT, Vasileios! We’re thrilled to have you on board 🎉

🌟 Excitement is building for the upcoming Nordic PV Day, and we can't wait to reconnect with all of you! Will you be attending? 💊 Our team from Drug Safety & Pharmacovigilance and Veeva Services, led by Louise Søgaard Nielsen and Maria Skou Andersen, will be present, along with our Business Development Manager, Lars Bak-Christensen, ready to engage and share insights. We look forward to seeing you at Nordic PV Day! 🚀 🗓 For more details about the event, click here 🔗 https://lnkd.in/dKs3wQES

🎓Another successful Clinical Development and Applied Good Clinical Practice (GCP) training wrapped up at Pharma IT Academy! 🎉 We were thrilled to have 16 engaged participants join our hands-on training, led by Maria Iversen and Birgitte Sloth. During the training, our participants: ✅ Learned the important GCP principles and how to apply them in clinical trial planning and execution. 🔍 Explored the various phases of clinical research programs, common study designs, and terminology. 🤝 Developed a comprehensive understanding of collaborative efforts among diverse stakeholders, including CROs and vendors, in clinical trials. 📅 Ready to take your knowledge to the next level? Join us on February 4th, 2025! Secure your spot here 🔗 https://lnkd.in/evqJBNNx

NIS2 IS NOW IN EFFECT 📢 The NIS2 Directive is the EU's updated cybersecurity directive aimed at strengthening the resilience of critical infrastructure sectors. NIS2 sets stricter security requirements and higher penalties for non-compliance, specifically targeting industries such as Pharmaceuticals, Biotech, and Medical Devices. Is your company ready for these changes? Organizations 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. Our 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 ensure your company is NIS2 compliant 🔗 https://lnkd.in/diFYXDfu

⚠️ Navigating the complexities of GAMP 5 and ensuring your computer systems meet regulatory standards can be difficult. Teams risk facing delays, inefficiencies, and non-compliance without the right expertise. Our 2-day GAMP 5 CSV Basics training covers the fundamentals you'll need to get started and equips you with practical tools, expert guidance, and ready-to-use templates to support successful validation and compliance. Whether you're new or need a refresher, this course offers invaluable hands-on experience. 📅 Dates: November 6-7, 2024 📍 Copenhagen 🔗 Secure your spot now: https://lnkd.in/eJyhFVWP

We get it — managing testing workflows, balancing manual and automated tests, and staying compliant can be overwhelming. That’s why our Automation & Analytics Team at Pharma IT developed TestMan! ⚙️💡 ✅ TestMan is an all-in-one test management solution built specifically for Azure DevOps. It integrates seamlessly into your existing workflows, allowing you to create, execute, and manage both manual and automated tests in a single platform. Plus, it’s designed with regulatory compliance in mind, making it easy to meet GxP and CFR 21 Part 11 standards. With TestMan, you: • Manage all your testing activities, manual and automated, in one place. • Stay compliant with built-in workflows that align with GxP and CFR 21 Part 11, complete with audit trails and approval workflows. • Streamline your testing processes and get clear visibility into test progress, allowing you to make quicker, data-driven decisions. 📩 Want to learn more about how TestMan can transform your testing processes? Contact Søren Winkel at sqwi@pharmait.dk today!