Industry leaders have embraced Risk Based Monitoring (RBM) as a method for:
• Improving clinical trial efficiency
• Streamlining resource utilization, and
• Delivering clinical trial cost savings.
However, implementing RBM is not without risk, including regulatory inspection risk. With the release of the EMA Reflection Paper in 2011 and the FDA Guidance in 2013 the use of RBM is increasing globally and regulatory agencies are now assessing the RBM practices implemented by sponsors. Are you ready?
This webinar will use the lessons learned from the early adopters of RBM, as well as, current industry best practices to inform those currently using RBM or those considering implementing RBM. Practical tools and actionable steps will help guide the implementation of a successful and inspection ready RBM program.
• Understand RBM in the wider Clinical Quality context
• Understand the key concepts and tools used for RBM
• Identify common RBM failures and how to avoid them
• Identify success factors and best practices used by industry leaders
• List 5 steps to ensure RBM practices are inspection ready
Who should attend
Clinical research professionals with a basic knowledge of ICH-GCP principles. Some knowledge of RBM is preferred but not required.
Meet the Presenter
Susan Gould, MBA, MS
Principal Consultant, Halloran Consulting Group
She has over 20 years of experience in the Medical Device and Pharmaceutical industry. She is an expert on clinical quality, compliance, and technical execution, including Quality Systems Regulation (QSR), Phase I-IV Clinical Trials, and Human Factors Evaluations.
Sue earned a Master of Business Administration from Lake Forest Graduate School of Management, with advanced certification in Business Analytics and Strategy Development. She also has a Master of Science degree in Clinical Microbiology from Thomas Jefferson University. She is certified in Quality Systems from Association for the Advancement of Medical Instrumentation.
Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after viewing the webinar. CEUs are not granted after the 30-day assesment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.
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