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Risk Based Approaches for Clinical Trials

Duration : 60 Minutes

Dr. Laura Brown,

Dr. Laura Brown is an independent QA and Training Consultant and Director of the MSc in Clinical Research, School of Pharmacy at the University of Cardiff and Course Director of the MSc Regulatory Affairs, TOPRA.  Laura has many years’ experience in the Pharmaceutical Industry. She has Read more

Risk management is becoming increasingly important to running clinical trials. There are now numerous pharmaceutical guidelines covering risk management including ICH Q9, the revised ICH GCP R2 guideline, the revised EU Clinical Trial Regulation guideline on risk management and several other risk management clinical research standards and initiatives.

This essential web-seminar will explain the importance of using risk management techniques in clinical research to comply with the latest focus on GCP inspection in this area. It will show you how risk management can improve the quality of your clinical trials and demonstrate the importance of using 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.

Course Objectives:

• Understand risk management tools and when and how the tools are used in clinical research projects
• How to plan risk based approaches for clinical trials
• How to document risks
• Where to focus to meet regulatory requirements and expectations for risk management
• Develop and apply risk management principles and tools to your clinical research projects
• Consider best practices for implementing risk based tools and principles
• Review best practice of these additional new risk management requirements

Course Outline:

• Understand the new requirements for risk management in clinical trials
• 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
• Have explained key risk based process/tools and techniques
• Review a risk based approach to protocol design
• Understand risk based approach to monitoring / data handling
• Hear best practice of these new risk requirements

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

Who Will Benefit:

Anyone working on clinical trials including

• CRAs, monitors,
• Clinical Development Managers and Personnel
• Clinical Research Associates (CRAs)
• Monitors
• Clinical managers
• Project managers
• Lead clinical research associates
• Data managers and statisticians
• Study managers, document management
• Clinical Research Archiving and Document Management Personnel
• Quality Assurance Managers and Auditors
• Clinical Development Managers and Personnel
• Consultants
• Regulatory Affairs Specialists
• Pharmacovigilance /Drug Safety
• Study Site Personnel

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register


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Subject : Risk Based Approaches for Clinical Trials

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