Course Information

Immerse yourself in the realm of clinical trial risk management with our comprehensive training programme, designed as an ideal pathway into this field. Tailored for individuals familiar with ICH Guidelines for Good Clinical Practice (ICH GCP E6(R2)) and ICH Guideline on General Considerations for Clinical Studies (ICH E8(R1)), this course pivots towards applying risk management principles to clinical trials. It's equally beneficial for professionals with quality or risk management experience from diverse disciplines. Prior experience in clinical trials and familiarity with the ICH Guidelines is recommended. 

Practical Emphasis:

Our course focuses intensively on the practical aspects of clinical trial risk management. Engage in workshops designed to provide firsthand experience in deploying risk management techniques within a clinical trial context. Guiding you through this journey are seasoned quality professionals, imparting theoretical knowledge through their rich practical experiences.

Key Learning Outcomes:

By the course's conclusion, delegates will:

• Gain a crystal-clear understanding of the objectives outlined in ICH Guidance E6 and E8 concerning risk management in clinical trials
• Uncover potential pitfalls in clinical trials and learn how robust risk management strategies can prevent serious compliance issues
• Understand the roles and responsibilities pertinent to risk management in the context of clinical trials
• Explore a range of techniques to identify and mitigate risks in clinical trials, reinforced with practical examples and supportive documents
• Expand your professional network, fostering opportunities for career advancement in auditing.

Benefits:

You will acquire:

• A thorough comprehension of the quality professional's role in facilitating clinical trial risk management activities
• Enhanced compliance with Good Clinical Practice standards by proactively identifying and mitigating risks before they escalate into serious compliance issues.

Interactive Structure:

Structured to foster active participation, delegates are encouraged to:

• Engage in vibrant discussions, idea development, and problem-solving
• Examine critical aspects of risk management within the context of clinical trials

This course is tailored for:

• QA Auditors tasked with reviewing risk management processes during audits, seeking a deeper understanding of the process
• Quality professionals involved in risk management processes
• Project Managers aiming to better grasp the identification of compliance risks within clinical trials