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Compliance for Risk Based Approaches for clinical trials including the New FDA RBM Guidance 2019
- Understand risk management tools including for RBM and when and how the tools are used in clinical research projects
- FDA RBM 2019 guideline explained for compliance
- How to plan risk-based approaches for clinical trials
- How to document risks management and RBM
- Where to focus to meet regulatory requirements and expectations for risk management including RBM
- Develop and apply risk management principles and tools to your clinical research projects
- Consider best practices for implementing risk-based tools and principles including RBM
- Review best practice of these additional new risk management requirements
Overview of the webinar
Risk management is becoming increasingly important for running clinical trials. There are now numerous pharmaceutical guidelines covering risk assessment and management and Risk-Based Monitoring (RBM) including the revised ICH GCP R2 guideline, EU Clinical Trial Regulation guideline, several other risk management clinical research standards and initiatives. In addition, the recent FDA’s guidance on RBM which proposes increased requirements implementation and documentation for RBM.
This essential web seminar will explain the importance of using risk management techniques including RBM in clinical research to comply with the latest focus on GCP inspection in this area including the new RBM FDA guideline. It will show you how risk management including RBM can improve the quality of your clinical trials and demonstrate the importance of using RBM, risk analysis and risk management techniques in clinical trials. You will learn how to identify, evaluate and also how to implement specific risk-based techniques for risk management used in clinical trials. Provides guidance on the latest FDA thinking for RBM. The seminar will provide recommendations on planning RBM, content of a monitoring plan, and addressing and communicating monitoring results to meet FDA and EU inspectors’ expectations.
Who should attend?
Anyone working on clinical trials including:
- Clinical Managers
- Project Managers
- Lead Clinical Research Associates
- Clinical Development Managers and Personnel
- Clinical Research Associates (CRAs)
- Monitors
- Data Managers and Statisticians
- Study Managers, Document Management
- Clinical Research Archiving and Document Management Personnel
- Quality Assurance Managers and Auditors
- Consultants
- Regulatory Affairs Specialists
- Pharmacovigilance /Drug Safety
- Study Site Personnel
Why should you attend?
- Understand the new requirements for risk management in clinical trials including the latest 2019 FDA guidance
- Define the regulations and guidelines which cover risk management applied to clinical study-level risk management
- Consider the elements of QM system are and what a regulatory inspector would expect to be in place for clinical trials including RBM
- Have explained key risk-based process/tools and techniques including RBM
- Review a risk-based approach to protocol design
- Understand approaches for RBM to meet FDA and other international inspectors’ expectations
- Hear best practice of these new risk requirements
Faculty - Dr.Laura Brown
Dr. Laura Brown is an independent Pharmaceutical QA, Management and Training Consultant and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 20 years' experience of Quality Assurance and managing international clinical trials including risk identification and management. She has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has consulted with numerous pharmaceutical companies, suppliers to the pharmaceutical industry as well as academic institutions.
Dr. Brown has an MBA with specialization in project management including risk management. She is also the external project management expert for a pharmaceutical e-learning MSc module in project management covering risk management and the author of two books on project management including the leading book “Pharmaceutical Project Management” (Gower).