GCP Risk Management And Risk-Based Monitoring
🎤 Charles H. Paul | 📅 March 06, 2025 | 🕒 11 AM Eastern Time US
Strengthen Clinical Trial Integrity with Risk-Based Monitoring
🚀 Do you fully understand how risk-based monitoring (RBM) enhances compliance? 🚀 Are your risk management practices aligned with FDA and ICH expectations? 🚀 Want expert insights on leveraging technology for clinical trial monitoring? This must-attend webinar is designed for professionals involved in clinical trial monitoring, compliance, and risk management, including: 👩⚕️ Clinical Research Associates & Monitors – Optimize monitoring practices to ensure regulatory compliance. 📊 Data Management & Project Teams – Strengthen trial oversight with risk-based strategies. 🛠 Regulatory & Compliance Specialists – Ensure adherence to global clinical trial regulations. 🏭 Clinical Research Outsourcing & Drug Suppliers – Understand risk-based monitoring’s impact on clinical supply chains. 💡 Trial Statisticians & Quality Assurance Teams – Leverage data-driven insights for enhanced trial quality. Applicable industries: Pharmaceuticals | Biotech | Medical Devices | Contract Research Organizations (CROs) | Clinical Research |
Ensuring patient safety, data integrity, and regulatory compliance in clinical trials is more challenging than ever. With evolving regulatory expectations, Risk-Based Monitoring (RBM) has emerged as a smarter, more efficient alternative to traditional monitoring methods—allowing organizations to identify, assess, and mitigate risks proactively.
This expert-led webinar explores the intersection of Good Clinical Practice (GCP) and risk management, equipping participants with the knowledge to enhance compliance and monitoring effectiveness. Led by Charles H. Paul, a 30+ year industry expert, this session will provide practical strategies to implement risk-based monitoring, leverage technology, and develop a robust risk management plan.
What You’ll Learn:
✔ Master GCP Compliance – Understand the foundational principles of Good Clinical Practice (GCP) and how they impact risk management.
✔ Navigate Regulatory Frameworks – Align risk management practices with FDA, EMA, ICH E6(R2), ISO 14155:2020, and 21 CFR Part 312 requirements.
✔ Implement Risk-Based Monitoring (RBM) – Learn how to transition from traditional monitoring to a risk-based approach.
✔ Develop a Robust Risk Management Plan – Identify, assess, and mitigate risks effectively using risk matrices and prioritization techniques.
✔ Utilize Technology for Enhanced Monitoring – Discover tools and data analytics solutions that improve clinical trial oversight.
✔ Mitigate Risks & Strengthen Compliance – Learn best practices to prevent protocol deviations, fraud, and regulatory non-compliance.
Key Areas Covered:
📌 Introduction to Good Clinical Practice (GCP) & Risk Management
📌 Regulatory Frameworks & Compliance Requirements – ICH E6(R2), ISO 14155:2020, 21 CFR Part 312
📌 Common Risks in Clinical Trials – Patient safety, data accuracy, protocol deviations
📌 Implementing Risk-Based Monitoring (RBM) – Transitioning from traditional monitoring approaches
📌 Building a Risk Management Plan – Risk identification, categorization, and mitigation strategies
📌 Leveraging Technology for Monitoring – AI-driven analytics, remote monitoring platforms
