Risk Management for Clinical Research Training Course

Course overview

Risk management is becoming increasingly important in clinical trials, as well as in ensuring compliance with regulatory expectations. Numerous pharmaceutical guidelines now cover risk management in clinical trials, including ICH GCP R2 and R3, and the FDA's Risk-Based Monitoring of Clinical Investigations: Questions and Answers guidance.

During this one-day course you will learn how to apply a risk-based approach when managing your clinical trials lifecycle. We will review the principles of risk management and how to apply them within a clinical trial setting according to ICH GCP R2 and R3.

This essential course will explain the importance of using risk management techniques in clinical development to comply with the latest focus on inspection in this area. It will show you how risk management can improve the quality of your clinical research projects and demonstrate the importance of using risk analysis and risk management techniques in clinical trials. You will learn how to identify, evaluate and implement specific risk-based techniques for risk management, including a quality management framework.

The course will enable you to develop quality risk management principles applicable to clinical trials, pharma, biopharma and device development, as well as to identify and share best practices for risk management tools and approaches.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

• Understand risk management tools and when and how the tools are used in pharmaceutical, biopharmaceutical and medical device projects
• Learn how to plan risk-based approaches, how to document and where to focus to meet regulatory requirements and expectations
• Develop and apply risk management principles and tools to your development projects
• Identify and share best practices for implementing risk-based tools and principles
• Gain a clear understanding of the objectives outlined in ICH Guidance E6 and E8 concerning risk management in clinical trials

Who should attend?

Anyone who is needs to understand risk management working in the pharmaceutical and medical device industry, including:

• Clinical research associates (CRAs)
• Clinical trial managers (CTMs)
• Quality assurance professionals
• Regulatory affairs specialists
• Project managers
• Data managers
• Those needing to understand the regulatory expectations, associated guidance and be able to apply different tools and techniques in their role.

Enrol or reserve