Brian Bbole, MSc’s Post

The Risk Based Quality Management Working Group are calling for volunteers on their latest project, ‘The Enhanced Risk-based Quality Management (RBQM) Approaches for First-in-Human and/or Small Clinical Trials’. This project aims to to discuss and focus on a robust strategy/process and best practises for: ↳Identifying critical items ↳Risk based data review approaches ↳Risk based monitoring approach strategy (tSDV/tSDR) ↳Usage of analytical tools and methods for data review & central monitoring, including limitations on (statistical) methodologies ↳Identification of thresholds or equivalent on limited patient data ↳Targeted medical review ↳Strategy to adequately anticipate on highly dynamic data ↳Establish links with the other work streams on FIH/small studies focus Please email workinggroups@phuse.global by 5 July to express your interest. Find Out More: https://lnkd.in/eAg8e4C5 #PHUSE

𝐃𝐢𝐬𝐜𝐨𝐯𝐞𝐫 𝐇𝐨𝐰 𝐭𝐨 𝐌𝐚𝐬𝐭𝐞𝐫 𝐀𝐝𝐯𝐞𝐫𝐬𝐞 𝐄𝐯𝐞𝐧𝐭𝐬: 𝐉𝐨𝐢𝐧 𝐎𝐮𝐫 𝐖𝐞𝐛𝐢𝐧𝐚𝐫 𝐓𝐨𝐦𝐨𝐫𝐫𝐨𝐰! 🚀 Don't miss out on a chance to gain powerful strategies for managing adverse events effectively! Tomorrow, we’re diving into real-life case studies to explore critical incidents, such as design flaws and software glitches, that impact patient safety and drive regulatory changes. 🏥📊 𝐖𝐡𝐚𝐭 𝐘𝐨𝐮’𝐥𝐥 𝐆𝐚𝐢𝐧:  🔍 𝐑𝐞𝐚𝐥-𝐋𝐢𝐟𝐞 𝐂𝐚𝐬𝐞 𝐒𝐭𝐮𝐝𝐢𝐞𝐬: Learn from past incidents and see how they’ve shaped regulatory practices. 🎓 𝐄𝐱𝐩𝐞𝐫𝐭 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞: Get actionable advice from Karolina Nożewska, a top expert in Quality Assurance and Regulatory Affairs, on mastering complex regulations and enhancing compliance. 🛡️ 𝐄𝐧𝐡𝐚𝐧𝐜𝐞𝐝 𝐑𝐢𝐬𝐤 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭: Discover practical techniques for identifying and addressing risks to ensure safer product development. 𝐖𝐡𝐲 𝐀𝐭𝐭𝐞𝐧𝐝? Adverse events affect more than just immediate harm—they impact patient safety, organizational trust, and financial stability. This session will equip you with essential strategies to refine your approach and improve your risk management practices. 📅 Secure Your Spot Now: https://lnkd.in/dScZmfvg Don’t miss this opportunity to transform your approach to regulatory compliance and risk management. We look forward to seeing you there! 🎙 Host Marcus Emne #Webinar #RegulatoryAffairs #QualityAssurance #RiskManagement #Compliance #Healthcare #AdverseEvents #Hoodin #RAQA

Delivering excellent healthcare service requires a two-pronged approach: quality management (QM) and quality assurance (QA). QM involves proactive measures to ensure consistent, high-quality care through standardized policies, performance monitoring, and continuous improvement. QA focuses on verifying adherence to these standards through internal and external audits, and incorporating patient feedback. By working together, QM and QA create a cycle of excellence in health systems, prioritizing patient safety, satisfaction, and compliance with regulations. This approach leads to a thriving health system that delivers exceptional healthcare and builds trust with patients. #OperationalExcellenceInHealthSystems #BuildingRobust&ResilientHealthSystems

📢 📢 Continuous Improvement in Healthcare Quality Management 🔻 What is it? ◾ A systematic approach to constantly improve the quality, safety, and efficiency of healthcare delivery. ◾ Focuses on data-driven decision-making and collaborative problem-solving. ◾ Aims to achieve better patient outcomes and increased staff satisfaction. 🔻 Methods: ◾ Plan-Do-Check-Act (PDCA) Cycle: Identify problems, implement solutions, measure results, adapt and improve. ◾ Lean Six Sigma: Reduce waste and variation in processes. ◾ Root Cause Analysis: Identify underlying causes of problems. ◾ Benchmarking: Compare performance with other organizations. ◾ Teamwork and Collaboration: Engage frontline staff in improvement efforts. 🔻 Benefits: ◾ Improved patient outcomes: Reduced wait times, fewer errors, better clinical results. ◾ Increased staff satisfaction: Improved communication, workload reduction, sense of ownership. ◾ Reduced costs: Eliminated waste, more efficient resource allocation. ◾ Enhanced regulatory compliance: Demonstrates commitment to quality improvement. 🔻 Obstacles: ◾ Lack of time and resources: Implementation requires dedicated effort and funding. ◾ Resistance to change: Staff may be hesitant to try new things. ◾ Data silos and poor communication: Difficulty accessing and sharing relevant data. ◾ Leadership commitment: Requires active support from leadership to sustain efforts. 🔻 Final 📌 Continuous improvement is a journey, not a destination. 📌 Small, incremental changes can lead to significant results over time. 📌 Everyone in the organization plays a role in quality improvement. 📣 📣 For more information you can visit this reference: https://lnkd.in/dUJjNeBe #continousimprovement #operationalexcellence #healthcare #qualityassurance #quality

Avoid Common Mistakes in Your QI/QA Plan 🚫📈 Are you part of an FQHC or look-alike, or thinking about becoming one? Navigating the regulatory requirements can be challenging, especially when drafting your Quality Improvement/Quality Assurance Plan. 👉 Steer clear of these top errors to ensure compliance and enhance your healthcare services. Interested in learning more? Follow the link in our bio to dive deeper into common pitfalls and how to avoid them! 🔗 For more insightful articles or to sign up for our newsletter, follow the link in our bio #QualityImprovement #HealthcareCompliance #FQHC

Excited to share my recent learnings on Quality Risk Management (QRM) in clinical trials! QRM is a systematic process ensuring data integrity and the protection of participants' rights and safety. Here’s a snapshot of what I’ve learned: Key Steps in QRM 1. Risk Identification 2. Risk Assessment 3. Risk Control 4. Risk Communication 5. Risk Review Key Considerations 1. Regulatory Compliance: Adhere to relevant regulations and guidelines like ICH E6 (R2) Good Clinical Practice (GCP). 2. Quality by Design (QbD): Build quality into the trial from the outset. 3. Cross-functional Collaboration: Engage various functional areas for a comprehensive approach. 4. Use of Technology: Leverage technology and data analytics tools for risk identification, monitoring, and reporting.   Benefits of Effective QRM 1. Improved Data Quality: Ensures reliable data for regulatory submissions and scientific validity. 2. Enhanced Participant Safety: Proactively identifies and mitigates safety risks. 3. Operational Efficiency: Streamlines processes, reducing disruptions and delays. 4. Regulatory Approval: Facilitates smoother reviews and approvals by demonstrating robust risk management practices. System-Level Risk Control 1. Documented Procedures: Establish SOPs, policies, and guidelines. 2. Contracts with Third Parties: Define roles, responsibilities, and quality expectations in agreements. 3. Communication Plans: Maintain regular communication channels internally and externally. 4. Tailored Training: Provide role-specific and ongoing training. 5. Quality Performance Measurement: Define metrics and conduct regular audits of service providers. Trial-Level Risk Control 1. Protocol Designs: Develop robust protocols with risk mitigation strategies. 2. Trial-Specific Training: Ensure comprehensive training for investigators and site staff. 3. Site Monitoring: Schedule frequent monitoring visits to ensure compliance. Quality Tolerance Limits 1. Trial Procedures: Set limits for protocol compliance, GCP, regulatory requirements, and SOP adherence. 2. Trial Management: Determine acceptable ranges for monitoring visit frequency, data management, query rate, safety management, temperature excursions, and protocol deviations. By integrating QRM into clinical trials, we can achieve significant improvements in data quality, participant safety, and operational efficiency. These practices not only streamline processes and reduce risks but also pave the way for smoother regulatory approvals. Investing in robust QRM strategies ultimately ensures the success and reliability of clinical trials, benefiting all stakeholders involved. #ClinicalTrials #QualityRiskManagement #QRM #GCP #ClinicalResearch #RiskAssessment #RiskControl #DataIntegrity #ParticipantSafety

Risk-based quality management: Can a system like #RbQM serve as an audit target? Yes, definitely! I explored this question in my presentation at the ACDM: Association for Clinical Data Management RbQM Symposium in Brussels this week. The symposium was mainly attended by data managers, risk managers and central monitors, so in my role as a GCP auditor I learnt a lot from my colleagues and gained a better understanding of how RbQM is implemented in data monitoring. If you take a holistic approach to the topic, it becomes clear how many opportunities there are for audits to verify RbQM processes at different levels. Be it at system level at the sponsor, during vendor qualification or when checking the effectiveness of the processes in the study sites. Risk-based audit programmes that focus on the previously identified critical processes at system and study level help to ensure data integrity and patient safety. There is a lot going on and I am convinced that E6(R3) will give us a further boost. High time for sponsors and CROs who are not yet living RbQM in their organisation to get to grips with the topic! _______ Repost ♻️ to share with others. Follow 🔔for more.

When it comes to designing your quality audit programme, how do you ensure that you’re getting high quality outputs? A strategic approach is required, which focuses on clear objectives, action-planning, and quality data tools. In this blog post, we share best practices for scheduling and structuring your audit programme to align with organisational goals and regulatory requirements, including 3 key steps to get started.✨ Take a read: https://buff.ly/4d1KVHj #Quality #Audit #Healthcare #Accreditation #Socialcare

The topic of Risk Management can be daunting at times - let's face that and accept it. Once accepted, let's take some time to understand what risk based thinking is and how it helps the organisations. There are a lot of processes and systems that may already in place in your quality management system. For risk based thinking, ask if you truly understand why the processes and systems are in place. Are they there because it makes things easier to manage? What would happen if you took it away? Important topic Christoph Ortland - thank you for sharing.