PQE Group

Rare diseases have often been treated as insignificant and unworthy of attention due to their limited prevalence, which has led patients to face tremendous challenges in accessing proper diagnosis, treatment, and support. As PQE Group we have made it our mission to leave no diseases and illnesses behind, regardless of their prevalence, by taking an innovative approach to the development of treatments and ensuring equitable access to care for all through initiatives like medical cannabis and femtech advocacy. This Rare Diseases Day, we are joining hands with patients affected by rare diseases to remind the world that rare does not mean less important.🤝✨ #RareDiseasesDay #Femtech #RareDiseasesAwareness

Join us at KENX University 2025 in 📍Philadelphia or Online 💻 from March 26-27! 📣 We are thrilled to announce that PQE Group is both sponsoring and actively participating in Validation University 2025, the must-attend event for professionals in QA, Validation, Engineering, IT, and Regulatory Affairs across the pharmaceutical, biopharmaceutical, and medical device industries to level up their industry knowledge and network with industry experts. With over 45 sessions lined up from Industry-Leading SMEs, Validation University is the ideal place to widen your process validation, enhance your regulatory knowledge, and explore emerging trends in AI, cloud systems, and continuous manufacturing. How You Will Benefit from Attending: 🔍 Gain actionable insights from expert-led sessions on the latest validation trends and best practices. 📈 Learn cutting-edge techniques for AI-driven validation, cloud-based systems, and continuous manufacturing. 🔄 Enhance your compliance strategies with deep dives into risk-based approaches and data integrity. 🛠️ Boost your operational efficiency with hands-on knowledge in process validation, facility qualification, and automated validation systems. 🤖 Stay ahead of the curve by exploring transformative technologies shaping the future of validation and regulatory compliance. 🎟️ Register now & secure your spot, and let's explore the latest validation trends and innovation at the link 👇🏼 https://lnkd.in/emNpt5E3

Our R&D and Scientific Team led by Niccolò Sturli, and Engineering Team guided by Mariella Di Franco have finally come together for our much-awaited annual meeting! 🎉   This gathering was a fantastic opportunity to share insights, align our vision, and strengthen the collaboration that drives PQE Group forward.   A heartfelt thank you to everyone for your dedication, hard work, and invaluable contributions to Life Sciences. Together, we are shaping a safer, more innovative future! 🚀💙   #AnnualMeeting #Teamwork #Innovation #LifeSciences #PQEGroup #StrongerTogether #Pharmacovigilance #Engineering

🚨 EMA's New Benefit-Risk Guidelines for Veterinary Medicines: Are You Ready? 🚨 The European Medicines Agency (EMA) is rolling out a major regulatory update that will impact all manufacturers of veterinary medicinal products 🐶🐰💊. Starting May 15, 2025, the updated Benefit-Risk Balance Guideline will require companies to go beyond the market authorization phase, ensuring a more comprehensive evaluation of their products throughout the entire lifecycle. So, what does this mean for the veterinary pharmaceutical industry? 🤔 🔎 New, stricter regulatory requirements will demand: ✅ More extensive clinical trial data to prove safety & efficacy 🌍 Detailed environmental risk assessments to evaluate ecological impact 🦠 Antimicrobial resistance (AMR) studies to address public health risks These enhanced standards aim to strengthen veterinary pharmacovigilance and ensure safer, more effective treatments for animals. However, they also bring new challenges for manufacturers in terms of data collection, reporting, and long-term compliance. ⚠️ Non-compliance is not an option—failing to meet these requirements could result in regulatory action or market access delays. 💡 Is Your Company Ready? Our Pharmacovigilance Compliance Expert, Leonardo Giraudo, breaks down the key changes and shares strategic advice to help you stay ahead of the curve. Don’t get caught off guard, read our full analysis below👇. 👉🏻https://hubs.ly/Q038kSbt0 #VeterinaryMedicine #Pharmacovigilance #RegulatoryCompliance #EMA #AnimalHealth #VeterinaryPharma #AMR #ClinicalTrials #PharmaRegulations

The future of life sciences is deeply intertwined with AI 🤖, as the technology is proving itself to be an essential tool in accelerating research 🔬 and ensuring better patient outcomes by leveraging its ability to process vast amounts of complex data with speed and precision. From biomarker discovery to personalized treatment 💊, AI is transforming how we approach healthcare and drug development. However, just like with any piece of technology, its effectiveness depends on how well it is implemented and managed, and for a highly regulated industry like life sciences, this means ensuring data security, compliance, and ethical AI use. Check out our new article on AI's key questions and critical considerations here 👉: https://hubs.ly/Q036YwFk0

📣📣📣 The countdown is on! We’re just 14 days away from the third installment of the PQE US Roadshow – ‘Innovations in Life Science’ in Cambridge! 🚀 If you haven’t reserved your spot yet, NOW is the time to secure your place at this exclusive industry event. Join us for a deep dive into AI-driven innovation in healthcare and gain valuable insights from top industry experts on: ✅ Harnessing AI to accelerate R&D and commercialization ✅ Optimizing data management across the entire product lifecycle ✅ Overcoming regulatory hurdles and mastering M&A strategies ✅ Scaling innovations for life sciences manufacturers This FREE event is a must-attend for professionals looking to stay ahead in the rapidly evolving life sciences and healthcare industries. 📅 When? March 11, 2025 📍 Where? CIC (Cambridge Innovation Center) 🌟 Meet our incredible panel of industry leaders: 🔹 Giuseppe Cognetti – Associate Vice President, Regulatory Data, Digital, and AI Business Head Sanofi 🔹 Boris-Stephan Rauchmann, MD, MHBA – Medical Doctor, Founder & CEO at Medotrax GmbH 🔹 Fehmida Kapadia, PhD – Entrepreneur, Medtech Advisor 🔹 Paolo Baroldi – Chief Medical Officer at Bloom Science Inc. and Principal Consultant at PQE Group 🔹 Tarun Walia – Senior Director, Data Science Strategy at Novo Nordisk 🔹 Bob Castellucci – Principal Consultant and Networking Executive at PQE Group This event is more than just a conference—it’s an exclusive networking opportunity! Connect with top AI and life sciences experts, exchange ideas, and explore new collaborations. And to top it all off, we’re bringing a taste of Italy to Cambridge with an authentic Italian aperitivo 🍷—the perfect way to wrap up an insightful day of learning and networking. 🎟️ Seats are filling up fast! Reserve your spot now: https://hubs.ly/Q02HWc-m0 #AIinHealthcare #LifeSciences #Innovation #R&D #RegulatoryCompliance #Medtech #PharmaTech #HealthcareAI #PQERoadshow

Che esperienza incredibile al Road Show – Innovazione nei Dispositivi Medici! 🚀 Grazie per essere stati con noi a Bologna durante questo evento straordinario! 📸🎥 #InnovazioneMedica #IntelligenzaArtificiale #StudioClinico #RoadShow

Unlike major pharmaceutical companies with vast resources, small pharmaceutical firms rely on Clinical Research Organizations (CROs) to navigate regulatory complexities during critical trials. 💊 While CRO teams provide expertise in key areas such as compliance ✅ and cost-effective budgeting 💰, their role goes beyond just a transactional relationship. For both parties to work in harmony and achieve successful results, CROs must be treated as collaborators and an extension of the sponsor’s team. 🤝✨ Read more about how Clinical Research Organizations and small pharmaceutical companies should approach clinical trials in our latest article by Paolo Baroldi, Chief Medical Officer at Bloom Science, Inc. here 👉: https://hubs.ly/Q037jvhZ0

With Windows 10 support ending this October, pharmaceutical companies relying on this operating system or older versions of Windows must decide whether to upgrade or continue using outdated systems for the sake of operational stability. Dario Palese, Partner and Digital Governance Business Line Director at PQE Group, dissects this dilemma and outlines how life sciences companies should navigate the transition. Learn more about The Challenges of Operating System Obsolescence in the Pharmaceutical Industry here: https://hubs.ly/Q037kjQp0 #PharmaTech #Cybersecurity #RegulatoryCompliance #PQEGroup #Windows11 #LifeSciences

AI is not just transforming how we interact with the digital world; it is also changing how life science organizations operate and innovate. Artificial intelligence has the potential to improve lives and drive breakthroughs we never thought possible if used responsibly and ethically. Recognizing the need for compliant and responsible AI technologies in line with regulatory standards and guidelines, PQE Group is thrilled to announce the launch of our first-ever AI-dedicated service page to help you keep up with regulations, industry trends, and most importantly get reliable support and resources to navigate the complex AI landscape in life sciences. Discover our AI solutions and how they can help your business 👉 : https://hubs.ly/Q036yTLB0