Risk Based Monitoring: What, Why & How?

Live Webinar

  • 90 minutes

Risk Based Monitoring (RBM) is the process of ensuring the quality of clinical trials by identifying, assessing, monitoring and mitigating the risks that could affect the quality or safety of a study

Session Highlights:

This webinar will review the key principles and processes that enable successful deployment of the RBM approach for a given study. It is critical to understand the study specific risk and mitigate them. Finally, Best Practices and metrics for running RBM studies will be presented.

Areas Covered in the Session:

  • What is it?

  • Why do we do it?

  • What are the critical types of data?

  • What risks should be mitigated?

  • What are the enablers for RBM?

  • What are the challenges in implementation?

  • Who owns Risk Based Monitoring?

  • Lessons learned from Risk Based Monitoring

Why You Should Attend:

The updated ICH E6 R2 guidelines (2016) have been introduced to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.ICH E6 R2 states that, “the sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials.The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring.

Who Should Attend:

  • Clinical Operations professionals

  • Medical monitors

  • Pharmacovigilance

  • Clinical data management professionals Project management professionals

  • Biostatisticians

  • All members of the study team

  • Consultants

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Mike Collins

Mike Collins

Seasoned Executive with 30+ years of experience in the Life Sciences Industry. Mike holds an undergraduate degree in genetics from the University of Sheffield.  Aa MSc in Applied Genetics and a doctorate on the quantitative genetics of behavior in fruit flies from the University of Birmingham. Originally a statistician by training Mike has extensive experience in all phases of clinical development at Hoechst, Pfizer & Alexion. Most recently Mike was Head of Global Clinical Operations & R&D Vendor Management at Alexion focusing on the development of medicines for ultra-rare diseases. Mike currently provides clinical development consulting services to a range of biotech clients. Mike is passionate about meeting the needs of patients and in optimizing the operational aspects of clinical program design, reporting and execution to ensure high quality data delivery.

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