Regulatory Considerations Expert Group
Regulatory Considerations Expert Group members
Silvia Perez Torres(Chair)
Although I started my career in the pre-clinical environment, once I completed my Ph Degree in Neuroscience, I moved to the clinical industry, working the majority of my career in Data Management, first in a small CRO company and later in the pharma industry.
For almost 12 years, I was managing phase III clinical trials acting as Global Data Manager Lead, coordinating end-to-end data management activities (including SDTM development) mainly outsourced to global CROs. Aside from the oversight of clinical trials, part of my role as an expert in DM was to lead standardization on E2E data and processes.
The last two years I have completely changed my role and moved to the Quality area, where I’m providing quality support to Biometrics functions (including DM, Programming and Statistics roles). Among other activities, I am giving quality related advice and guidance, overseeing quality issues, CAPA implementation and risk management and providing support on audit and inspections, as well as preparing teams to be inspection ready at all times.
|Silvia Perez Torres (Chair)