QbD Group

In today’s competitive life sciences market, a website is more than a digital presence—it’s a critical tool for connecting with your audience and driving growth. Yet, many organizations struggle to translate complex scientific expertise into compelling online content. 💻🧬 That's why we are hosting the webinar ‘Website storytelling: turning science into engagement’ on December 10 at 16:00 CET. 🎙️ Led by our expert Kim Stevens, this session will provide you with practical strategies for creating content that conveys your scientific story while also being accessible and engaging. 🔗 Register here: https://hubs.li/Q02ZFVN80 #Storytelling #Science #LifeSciences

Last week, QbD Group had the honor of hosting the first-ever in-person event for the RAPS Belgium Local Networking Group! 🎉 We delved into the exciting world of Precision Medicine and Combination Devices, thanks to our incredible speakers Jeroen Pieper, Marina Belonogova, and Kirsten Van Garsse. 👏 What’s the goal of a local networking group like this? To build and connect local communities, showcase the value Regulatory Affairs Professionals Society (RAPS) brings to the industry, and support both professional and personal development. 🌟 Interested in joining this network? Reach out to rapsbelng@gmail.com. #Networking #RegulatoryAffairs #RAPS #RAPSBelgium #PrecisionMedicine #CombinationDevices

Did you know that impurities can compromise patient health? Even minute amounts of these unwanted substances can trigger adverse reactions, allergies, liver toxicity, or even mutagenic effects. ⚠️ That's why we've created a whitepaper where we delve into the toxicological assessment of organic and mutagenic impurities in medicinal products and its guidelines. A critical step in ensuring the safety and efficacy of pharmaceuticals. ✔️ Access the whitepaper here: 👇 https://hubs.li/Q02W0bHm0 #Pharma #Impurities #PatientSafety

We’re happy to highlight another heartwarming initiative from our QbD Group Foundation. ✨ In partnership with KATR!NAHOF, a remarkable non-profit that supports children, young people, and adults with disabilities, we sold a beautiful collection of 8 holiday greeting cards at our HQ over the past few months. These cards beautifully embody the spirit of the season, making them the perfect way to spread some JOY. ❄️🎄 They flew off the shelves, with all proceeds going towards our QbD team's 100-km run for ‘Kom Op Tegen Kanker.’ 🏃♂️💪 Thank you to everyone who purchased these greeting cards! #Partnership #GivingBack #QbDGroupFoundation

For medicinal products, the Product Information (PI) is a key document that provides a summary of officially approved information for both Healthcare Professionals (HCPs) and patients. Precision and clarity are everything—especially when it comes to translation. 💊 That’s where the European Medicines Agency (EMA)’s Linguistic Review steps in. This essential process ensures that every word in the PI is accurate, consistent, and compliant across Europe.🌍✔️ Want to know more? Dive into our blog to explore the EMA’s linguistic review process and key timelines, 👉 https://hubs.li/Q02VCYYd0 #MedicinalProducts #LinguisticReview #EMA #Compliance #Regulatory

🔍 When Does Annex XIV Apply in IVD Performance Studies? Navigating the #IVDR can feel overwhelming, especially when it comes to determining whether Annex XIV applies to your performance study. Don’t worry—we’re here to simplify it for you! In the fourth video of our six-part series, Kirsten Van Garsse and Sara Van Wouwe break down: ✔️ When Annex XIV applies based on Articles 58(1), 58(2), and 70. ✔️ Key triggers for authorization versus notification. ✔️ Best practices for preparing your application, from ethics approvals to documentation. 🗓 Join us on December 5 for the webinar 'Mastering Clinical Performance Studies under IVDR', where we’ll go even deeper into these topics and answer your questions live. 🔗 Register here for the webinar 👇 https://hubs.li/Q02YT0vS0 💡 Don’t miss next week’s video where we’ll explain what key documentation is needed to comply with Annex XIV! #IVD #IVDR #ClinicalPerformance #AnnexXIV

Sterilization validation is a vital process in the healthcare and pharmaceutical industries. It ensures that sterilization methods are not just effective but consistently reliable, making sure products are free from harmful microorganisms. 🔬 In this blog post, we’ll break down why sterilization validation is essential, the steps involved, and how to navigate common challenges. 👉 https://hubs.li/Q02W04TG0 #SterilizationValidation #PatientSafety

New advancements in medical technology —from innovative diagnostic tools to implants and wearables—are transforming healthcare as we know it. But with great innovation comes the need for heightened vigilance. This is where technovigilance steps in. 🔐🔎 In our latest blog, we explore how technovigilance is essential for post-market surveillance, helping safeguard patients by addressing risks, ensuring compliance, and implementing best practices. 👉 https://hubs.li/Q02W05dP0 #Technovigilance #Vigilance #Healthcare #MedicalDevices

❓What are the requirements for clinical performance studies under IVDR? Uncertain about the specific requirements for clinical performance studies under the IVDR and ISO 20916? We've got you covered! In the third video of our IVDR series, Kirsten Van Garsse and Annelies Rombout break down the key elements you need to know. 💡 Learn about key standards, best practices, and how to stay compliant. And don’t forget — our upcoming Mastering Clinical Performance Studies webinar on December 5 will take a deeper dive into these insights. 🗓 🔗 Register here for the webinar 👇 https://hubs.li/Q02Y2Yht0 #IVD #IVDR #ClinicalPerformance #MedTech #Webinar #HealthcareInnovation

Imagine your pharmaceutical company has rolled out new software to manage drug manufacturing processes, confident in its validation. But was it thoroughly tested? 🤔 Computer System Validation (CSV) is essential to ensure that systems work as intended, meet regulatory standards, and deliver consistent quality. Without comprehensive CSV, issues can slip through, risking incorrect batch records, delayed product releases, and costly compliance breaches. 🚨 In our latest blog post, we dive into how combining scripted and unscripted testing ensures robust CSV for compliance, accuracy, and system reliability. 👇 https://hubs.li/Q02W04Tr0 #CSV #ComputerSystemValidation #Pharma