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EMA has released new guidance on the anonymisation of protected personal data and commercially confidential information during the preparation of risk management plans (RMPs). The document provides general guidance to applicants and marketing authorization holders (MAHs) on the retention and removal of personal data and identification of commercially confidential information. The recommendations in this guidance are of an editorial nature and should be implemented in the RMP during the scientific review of a medicinal product. Any changes not implemented before approval should be considered for redaction post-approval, with the aim of publishing the RMP on the EMA product page. Stay informed and ensure compliance with the latest guidance to prepare effective RMPs. #EMA #RMP #guidance #compliance #medicinalproduct Read more below:

Unleash your potential at these intensive courses and master the art of #pharmacovigilance 💻 Introduction to Statistics in Pharmacovigilance Instructor - Lesley Wise January 24, 2024, 10:00 AM - 2:00 PM ET | Virtual - Importance of denominators and numerators in risk measurement and presentation - Common approaches to measuring and presenting risk - Standard methods for comparing risks, relevance, and interpretation - Concepts of variability and statistical significance in risk assessment - Differentiating between Meta-analysis and pooled analysis in statistical evaluation - Awareness of common statistics abuses in pharmacovigilance 🏙 Aggregate Safety Assessment Planning (ASAP) Process Instructors: Barbara Hendrickson & Greg Ball February 4, 2024, 9:00 AM - 4:00 PM ET | In-Person - Assess data using ASAP process to address safety concerns from diverse stakeholders - Understand the DAISE template to guide sponsor teams in clinical development - Support multidisciplinary safety planning, ongoing aggregate safety evaluation, and IND safety reporting decisions - Evaluate product-level safety data, impacts, and benefit-risk assessment 🏙 Good GVP Operations Development – From Clinical Trial to Post Marketing Instructor: Catherine B. February 4, 2024, 9:00 AM - 4:00 PM ET | In-Person - Explore pharma development processes from clinical trials to post-marketing - Examine laws in the US, EU, and other regions, and learn to translate them into operational practices - Operationalize regulatory requirements, covering staffing, vendor selection, process implementation, and post-market preparation - Gain real-world lessons from starting a safety unit at a small biotech Integrate legal compliance, practical implementation, and real-world examples Register for 2 or more and save! Register Today: https://lnkd.in/gVGeC-Rf #GPVRMS24 #DIA #clinicaltrials #GVP #ASAPProcess #statistics

Signal Detection & Risk Management 1. Live eLearning Weekend Sessions with Signal Detection Software Training 2. LMS Access - PPTs, Notes, Modules, Session Recordings 3. Certification - Cliniminds USA ACCRE Accredited Duration - 2 Months / 30 Hours Batch Commencement Sunday 14th July 2024 #SignalDetection #Pharmacovigilance #DrugSafety #AdverseEventReporting #PatientSafety #RiskManagement #SafetyMonitoring #DataAnalysis #MedicalMonitoring #Pharma #ClinicalTrials #Pharmacology #RegulatoryAffairs #Healthcare #SafetyScience #AdverseEvents #Vigilance #DrugSurveillance #MedicationSafety #ClinicalResearch #Pharmacovigilance #DrugSafety #PatientSafety #AdverseEvents #MedicalMonitoring #ClinicalTrials #RiskManagement #DrugRegulation #HealthCare #MedSafety #Pharma #RegulatoryAffairs #SafetyMonitoring #Pharmaceuticals #DrugDevelopment #Pharmacology #SafetyScience #Vigilance #MedicationSafety #ClinicalResearch

RISK MANAGEMENT AND MITIGATION | PROACTIVE RISK MANAGEMENT STRATEGIES: HANDLING THE EU QPPV ROLE   As a Contract Research Organization (CRO), we understand the critical importance of effective #riskmanagement, especially when assuming the role and responsibility of EU Qualified Person for Pharmacovigilance (#QPPV) for our valued customers.   What does it take to excel in this pivotal role? Here are some proactive strategies we advocate:   1️⃣ Clear Communication Channels: Establishing transparent #communication pathways with all stakeholders ensures that potential risks are promptly identified and addressed. 2️⃣ Robust Training Programs: Equipping our team with comprehensive #training not only enhances their expertise but also fosters a proactive risk-aware culture within our organization. 3️⃣ Stay Abreast of Regulatory Updates: Vigilance is key! Remaining updated with the latest regulatory guidelines empowers us to adapt swiftly to evolving #compliance requirements. 4️⃣ Implement Proactive Monitoring Systems: Utilizing advanced monitoring #tools enables us to detect potential risks early on, facilitating timely intervention and mitigation. 5️⃣ Encourage Collaborative Partnerships: By fostering collaborative #partnerships with our customers and other stakeholders, we collectively strengthen our risk management framework, enhancing patient safety and regulatory compliance.   At GB Pharma, we are committed to proactive risk management, ensuring the highest standards of #safety and compliance for our clients. Together, let's navigate the complexities of the EU QPPV role with confidence and diligence. Maria Chiara Vino   #Pharmacovigilance #RiskManagement #DrugSafety #RegulatoryCompliance #EUQPPV #Compliance #CRO #CROExcellence

This online training from our medical devices series focuses on ISO14971 and regulatory requirements on your risk management. Head to our website to see the full training agenda, read through the discussion topics and find out about the expert trainer behind this course. Follow the link in the comments. #pharma #medicaldevices #riskmanagement #ISO14971 #onlinetraining

#RiskManagement is such an important facet of the #MedDevice process, especially with the probable upcoming FDA changes to #QMS requirements. #MedicalDeviceManufactuing #ImprovingPaitentsLives #ISO13485 #SafetyMatters #RegulatoryCompliance #QualitySystemRegulation

Overview of RMP (Risk Management Plan): The aim of a risk management plan (RMP) is to document the risk management system considered necessary to identify, characterize and minimize a medicinal product’s important risks. To this end, the RMP contains: 1.      The identification or characterization of the safety profile of the medicinal product, with emphasis on important identified and important potential risks and missing information, and also on which safety concerns need to be managed proactively or further studied (the ‘safety specification’); 2.      The planning of pharmacovigilance activities to characterize and quantify clinically relevant risks, and to identify new adverse reactions (the ‘pharmacovigilance plan’); 3.      The planning and implementation of risk minimization measures, including the evaluation of the effectiveness of these activities (the ‘risk minimization plan’).  Most important overall principle of RMP is to ensure benefit of a product exceeds risk by the greatest achievable margin as possible for: 1.      Individual patients 2.      Population as a whole. Principle of RMP stays same regardless of stakeholders and across territories. Objectives of RMP As per IR 520/2012, elements of RMP include: ·        Identify and characterize safety profile of a product ·        Indicate how to further characterize the safety profile ·        Document measurements to prevent or minimize the risks associated with use of the product ·        Document post-authorization measurements which are obligations as per approval at the time of granting marketing authorization. ·        Describe what is known and what is not known about the safety profile of a product ·        Indicate level of certainty to which the efficacy shown in clinical trial populations will also be seen when product is used in the general population ·        Indicate how the effectiveness of the Risk Minimization Measures (RMMs) will be ascertained RMP is a legally binding document (just like PSUR) Legal basis of RMP (also same as PSUR): ·        Regulation (EC) No 726/2004 ·        Directive 2001/83/EC ·        Commission Implementing Regulation (EU) No IR 520/2012 Additionally, relevant ICH document for RMP is ICHE2E. RMP document = written agreement applied as a condition of registration An applicant/marketing authorization holder is responsible for: having an appropriate risk management system in place. Important to understand the difference between these terms: Regulations vs directives. # Pharmacovigilance #drug safety # EMA # RMP

📘 Harmonizing ISO 14971:2019 and FDA #QMSR for Medical Device Safety Navigating the complexities of risk management for #medicaldevices is crucial for ensuring safety and compliance. Our latest blog explores the integration of ISO 14971:2019 and the newly implemented #FDA Quality Management System Regulation (QMSR). 📚 𝐑𝐞𝐚𝐝 𝐭𝐡𝐞 𝐟𝐮𝐥𝐥 𝐛𝐥𝐨𝐠 𝐡𝐞𝐫𝐞: https://lnkd.in/gN7jFcB3 In this blog, you will learn: ✅ Key changes in the FDA QMSR and its alignment with ISO 13485  ✅ Importance of risk management in medical devices and IVDs  ✅ Strategies for aligning QMSR with ISO 14971:2019  ✅ Effective risk-based decision-making and #CAPA processes  ✅ How Celegence can assist with seamless #QMS transitions 🔍 𝐍𝐞𝐞𝐝 𝐞𝐱𝐩𝐞𝐫𝐭 𝐠𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐨𝐧 𝐢𝐦𝐩𝐥𝐞𝐦𝐞𝐧𝐭𝐢𝐧𝐠 𝐚 𝐫𝐨𝐛𝐮𝐬𝐭 𝐫𝐢𝐬𝐤 𝐦𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐟𝐫𝐚𝐦𝐞𝐰𝐨𝐫𝐤? Celegence offers comprehensive services to help you navigate the #regulatory landscape and ensure compliance. Discover how we can support your QMS needs: https://lnkd.in/g9bGxh6U #RiskManagement #ISO14971 #FDAQMSR #RegulatoryCompliance #HealthcareIndustry #Celegence #IVDCompliance #RegulatoryAffairs

🔍💣 Are You Effectively Managing Risks in Your Quality Control Processes? In the pharmaceutical and in vitro diagnostics sector, ensuring the safety and efficacy of our products is paramount. But how effectively are we managing the risks inherent in our quality control processes? Let's explore some best practices to address this critical aspect: 🔔 One of the first steps in effective risk management is proactive risk identification. By fostering a culture of learning and continuous improvement, where employees are not afraid of speaking up and reporting concerns or findings, we can uncover potential issues before they escalate. 📐 Once risks are identified, conduct a detailed analysis of the potential impact and probability of occurrence of each identified risk. By focusing on the most critical risks, we can ensure that our efforts are directed where they're needed most. 💉 Prevention is often the best cure when it comes to risk management. From process improvements to staff training, there are numerous ways to proactively address risks before they materialize.   ⚙ Risk management doesn't stop once preventive measures are in place. Regular monitoring will ensure that our risk management strategies are effective, that any new threats that may arise are detected and timely adjustments are made to keep risks under control. By adopting these best practices, we can strengthen our ability to identify, evaluate, and effectively manage risks in our quality control processes, thus ensuring their robustness, the quality and safety of our products and the satisfaction of customers. #RiskManagement #QualityControl #PharmaceuticalIndustry #InVitroDiagnostics #ContinuousImprovement

Notified Bodies and regulatory agencies expect significant risk management activities to be conducted during the development of a medical device, as well as throughout the production and post-production aspects. This includes training, equipment and process issues, purchasing and supplier monitoring, CAPA and complaints and non-conforming products. In this webinar, the presenters will help attendees develop a greater understanding of the application of the principles of risk management during all phases of the medical device lifecycle and the quality system processes that are impacted by its application. The presenters will provide some examples of risk application in several instances.