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San Diego Convention Center

23 jun 2019 1:30 p.m. - 23 jun 2019 5:00 p.m.

111 W Harbor Drive, , San Diego, CA 92101 , USA

#34: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model

Instructors

Barbara  Suarez

Barbara Suarez

Director, Clinical Study Support, GlaxoSmithKline, United States

Barbara A. Suarez, M.S., Director of Clinical Study Support for the US Local Operating Company at GlaxoSmithKline Pharmaceuticals. Over the course of 20 years within the industry, Barbara has served in diverse roles of increased responsibilities within Clinical Operations. Since 2013 she has been supporting the implementation and embedding of Risk Based Monitoring at GSK. Areas of experience and focus include assessing organizational readiness for change, defining adoption strategies, supporting process development and coaching and supporting solution teams on change management. In addition to her responsibilities at GSK she also represents her organization on TransCelerate’ s Risk Based Monitoring Work Stream beginning in 2014.

Rodrigo  Perez, RPh

Rodrigo Perez, RPh

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 degree in Pharmaceutical Chemistry. Since 2016 Rodrigo took a partial role of Risk-Based Monitoring (RBM) Project Leader, which evolved to Risk Management and Monitoring Lead full-time role. In this capacity, Rodrigo is currently working to align the global implementation of RBM in the CSU. He is the main point of contact to facilitate RBM adoption by mobilizing local study teams in stretch communication with global departments, ensuring processes harmonization.

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