QbD Group’s Post

✨ Webinar Experience on Pharmacovigilance ✨ I recently attended an insightful webinar on Pharmacovigilance, conducted by MEDWEB and delivered by @Dr. Aroosa Akber. The session highlighted the importance of: 💊 Auxiliary labels in ensuring safe medication use 📋 Rechecking prescriptions and verifying dose strengths ⚕️ The critical role of pharmacovigilance in monitoring and ensuring drug safety It was truly an informative and engaging session, where I gained valuable knowledge about the importance of pharmacovigilance in clinical practice and patient safety. A huge thank you to MEDWEB for organizing this wonderful session and to @Dr. Aroosa Akber for making complex concepts easy to understand and apply. #Pharmacovigilance #DrugSafety #HealthcareEducation #MedWeb #ContinuousLearning

🚀 New Article Alert! We’re excited to share our latest interview with Debora De Franciscis, QPPV, who dives into her experience navigating three very different pharmacovigilance (PV) system implementations: 1️⃣ Taking over an existing PV system and driving continuous improvement 2️⃣ Building a PV system from scratch after a company’s first Marketing Authorisation 3️⃣ Integrating an acquired company’s PV system into a global framework Debora shares practical insights on optimising processes, implementing robust governance, leveraging technology, and fostering a culture of patient safety—demonstrating that pharmacovigilance is not just about compliance, but also about creating sustainable frameworks that strengthen long-term company value. 💡 Want to discuss these PV challenges or explore innovative solutions? Our PV team will be attending the World Drug Safety Congress Europe next week and would love to connect ➡️ https://zurl.co/NdHw0 📖 Read the full interview here: https://zurl.co/vFEDo #Pharmacovigilance #QPPV #PatientSafety #PVSystems #WorldDrugSafetyCongress #LifeSciences

Pharmacovigilance — Booth 81 | AusBiotech 2025 Drug safety is more than compliance — it’s about protecting patients and ensuring scientific integrity from development to post-marketing. At My Medical Department , we provide end-to-end Pharmacovigilance solutions for biotech and CRO partners, including: 🔹 Safety database hosting and management 🔹 Case processing and expedited reporting 🔹 Aggregate reports (DSURs, PBRERs, RMPs) 🔹 QPPV and local PV services across Australia, NZ, and the UK Our team supports clinical and post-marketing programs, ensuring full regulatory compliance and efficient safety reporting — from first-in-human studies to commercial products. If you’re attending #AusBiotech2025, visit Booth 81 to discover how our integrated PV systems and flexible service models can strengthen your drug safety operations. #Pharmacovigilance #DrugSafety #QPPV #ClinicalTrials #MyMedicalDepartment #PVSystems #BiotechAustralia #AusBiotech2025

Think about the last ICSR you handled. Could you confidently defend every data point and timeline? In pharmacovigilance, the path from a reported symptom to a validated safety signal is complex. It demands precision, consistency, and a deep understanding of global guidelines. GVP Module VI isn't just another document—it's the essential playbook for getting the basics right. It details everything you need to know about: 🔍 Sourcing: Where and how to collect high-quality case information. 🗂️ Management: Structuring your data for accuracy and analysis. 📤 Submission: Meeting critical expedited and periodic timelines. A robust process here doesn't just ensure compliance; it actively protects patients. We've broken down the key takeaways from the module in our new article. 👉 Read it now and audit your process: https://lnkd.in/diHS-emA #ALVigilance #Pharmacovigilance #ICSR #GVP #PatientSafety #DrugDevelopment #PharmaCompliance #QualityManagement #LifeSciences

Local Safety Databases: A Global Overview Local Safety Databases (LSDs) are critical tools in pharmacovigilance, enabling faster detection of adverse drug reactions and compliance with national reporting timelines. 🌍 While VigiBase (WHO-UMC) serves as a global database supporting international signal detection, national authorities — such as the EMA, FDA, SFDA, NMPA, and ANVISA — maintain local databases tailored to their regional needs. 💡 Why they matter: Ensure timely and accurate adverse event reporting. Support localized signal management and faster regulatory action. Strengthen the bridge between global safety data and national decision-making. 📖 Explore how local databases complement global systems in our latest blog 👉 https://lnkd.in/ddihkygc ✍️ Authored by: Lamees El-Heeny, Head of Pharmacovigilance, Baupharma #Baupharma #Pharmacovigilance #DrugSafety #PatientSafety #RegulatoryAffairs #PharmaCompliance #VigiBase #SafetyDatabases #GlobalHealth

Did you feel that tremor? 💥 That was the PV regulatory landscape shifting below your feet, again… 🇪🇺 EU: Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national level – Human medicines requirements [Update] 🇮🇸 Iceland: Guidance on Safety Information [Update] 🇬🇧 UK: MHRA Updates Clinical Trials Hub with New Guidance Ahead of 2026 Regulatory Change [Update] 💌 Want these updates delivered straight to your inbox every week, free of charge? Sign up here: https://hubs.li/Q03MVg2s0 #drugsafety #patientsafety #pharmacovigilance

💊 ADR vs AE — Know the Difference! In pharmacovigilance, understanding terminology precisely is crucial. Many use Adverse Event (AE) and Adverse Drug Reaction (ADR) interchangeably — but they mean very different things. ✅ Adverse Event (AE): Any undesirable medical occurrence after using a drug — not necessarily caused by the drug. ⚠️ Adverse Drug Reaction (ADR): A harmful or unpleasant reaction directly linked to the use of a medicinal product at normal doses. 🧠 In short: > Every ADR is an AE, but not every AE is an ADR. 💭 Question for you: Do you think healthcare professionals receive enough training to differentiate ADRs from AEs during clinical trials and post-marketing surveillance? Let’s discuss 👇 #Pharmacovigilance #ADR #AdverseEvent #DrugSafety #ClinicalResearch #PharmaWorld #HealthcareProfessionals #PharmaLearning #PVInsights #PharmaPosts

Reflecting on the World Drug Safety Congress in Amsterdam: A Deep Dive into Structured Benefit-Risk Assessment Yesterday, I had the privilege of moderating a panel discussion at the World Drug Safety Congress in Amsterdam, where we explored an evolving area in pharmacovigilance: structured benefit-risk assessment (sBRA). As medicines become more complex and patient perspectives increasingly important, the need for transparent, reproducible, and data-driven benefit-risk frameworks has never been greater. Our panel brought together perspectives across different stakeholders to discuss: 🔹 How different methodologies can support decision-making 🔹 The role of patient-centric data in shaping benefit-risk profiles 🔹 Challenges in operationalizing sBRA across global regulatory landscapes 🔹 Opportunities to embed sBRA into the entire product lifecycle—from development to post-marketing surveillance What stood out most was the shared commitment to evolving our tools and thinking—not just to meet regulatory expectations, but to truly serve patients better. I’m inspired by the energy and collaboration in the room, and I look forward to continuing this dialogue.   #PatientSafety #Pharmacovigilance #BenefitRisk #sBRA #WorldDrugSafetyCongress #PatientCentricity #BoehringerIngelheim

💊 ICSR Processing: Case Receipt and Case Validity — The Backbone of Pharmacovigilance Operations Every Individual Case Safety Report (ICSR) marks the beginning of a drug safety journey. Before it contributes to signal detection or regulatory submissions, two fundamental steps ensure its quality — Case Receipt and Case Validity Assessment. These steps may seem routine, but they define the accuracy, compliance, and credibility of the entire pharmacovigilance process. 🔹 What is ICSR Processing? ICSR processing is the systematic workflow through which adverse event data is: 1️⃣ Collected 2️⃣ Verified 3️⃣ Validated 4️⃣ Coded and medically reviewed 5️⃣ Submitted to regulatory authorities It transforms a spontaneous report into meaningful safety intelligence. 🔹 Case Receipt — The Starting Point Case receipt is the first operational stage of ICSR processing. It involves capturing and logging incoming safety information from diverse sources such as: • Spontaneous reports (patients, HCPs) • Clinical trials and post-marketing studies • Literature and social media monitoring • Partner or regulatory authority exchanges ✅ Key tasks during case receipt: • Assigning a unique case number • Recording the date of receipt (critical for regulatory timelines) • Identifying the source and seriousness • Acknowledging receipt to the sender • Forwarding to data entry and triage teams 🔹 Case Validity — The Compliance Checkpoint Before a report can become an official ICSR, its validity must be confirmed. According to ICH E2D and GVP Module VI, a case is valid only if it contains the four minimum criteria: 1️⃣ An identifiable patient (age, initials, gender, etc.) 2️⃣ An identifiable reporter (HCP or consumer) 3️⃣ A suspect drug or product 4️⃣ An adverse event/reaction #Pharmacovigilance #DrugSafety #PatientSafety #ICSR #CaseProcessing #CaseValidity #SignalDetection #RegulatoryAffairs #ClinicalResearch #GVP #ICHE2D #LifeSciences #PatientSafety

Are you eager to stay ahead of the curve in pharmacovigilance? Look no further - the Oct edition of the Drug Safety Solutions newsletter is now available! This issue covers: ✅ News from the EMA ✅ Information on DSSL services with emphasis on PV Database Support, and who to contact for a quote ✅ Upcoming Training & Events