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Sunday, June 14 • 9:00am - 12:30pm
SC24: #24: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model

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Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-20-503-L04-P; CME 3.25; IACET 3.25; RN 3.25

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The current clinical trial climate demands that sponsors find ways to reduce clinical trial complexity, drug development costs, and get more value from R&D budgets. Risk-based monitoring (RBM) allows organizations to target site monitoring activities for which risks can be best managed and deliver the greatest benefit to the study, and to become more effective and efficient in using resources, while increasing quality and patient safety. Participating TransCelerate Member Companies came together in 2012 to establish a model approach to high-quality RBM. To date, this effort has published a position paper on risk based monitoring, as well as several articles focused on sharing advancements, best practices and lessons learned from member companies adoption experience, all of which are publicly available. This short course, will define core concepts and main principles of the methodology, share key tools and discuss their use, share experiences and lessons learned, and address important questions about RBM and its implementation.
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Who should attend?

This short course is designed for professionals involved with clinical and data operations.

Learning Objectives

Define core concepts and main principles of the risk-based monitoring (RBM) methodology; Discuss the use of key tools in the RBM process; Identify common challenges with effective monitoring and discuss how they can be addressed through appropriate use of the RBM methodology.


Speakers
avatar for Rodrigo Perez

Rodrigo Perez

Risk Management and Monitoring Lead, Sanofi, Mexico
Rodrigo Perez, based in Mexico City, has more than 14 years of experience in clinical research working for Sanofi’s Clinical Study Unit (CSU) in different roles (CRA, Study Manager, and Operations Manager, among others). Graduated from Universidad La Salle, Rodrigo has a bachelor’s... Read More →
avatar for Samantha Hewlett

Samantha Hewlett

Risk-Based Study Execution Capability Lead, Amgen, South Africa
Samantha qualified as a pharmacist and has worked in the pharmaceutical industry in varying roles and countries for over 20 years. She moved back to South Africa in 2014 and transitioned in to clinical research where she lead local clinical operations for both GSK and Amgen. She has... Read More →


Sunday June 14, 2020 9:00am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044