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Virtual Event

2021年6月22日 (火) 午後 1:00 - 2021年6月22日 (火) 午後 4:00

Horsham, PA 19044

#023P: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model


Samantha  Hewlett, RPh

Samantha Hewlett, RPh

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 been actively involved in the local pharmaceutical industry chairing research associations and committees. Samantha is a member of the Transcelerate RBM working group and for the last 3 years has been focusing on evolving the risk-based monitoring model at Amgen.

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.