Regulatory Considerations DMEG

Regulatory Considerations Expert Group

The Regulatory Considerations Expert Group looks at providing guidance information on a number of areas surrounding regulations. These include, where to find regulations and being aware of any new ones. Which parts are relevant to data management and what they mean. The expectations and recommendations on implementation and what data management needs to be prepared for in readiness for inspection.

The Regulatory Considerations group aims to further the development and skill-set of our wider ACDM community and would be delighted to invite members to our team. We look forward to hearing from you.

If you have any interest in joining this group, please click here.

Regulatory Considerations Expert Group members

Silvia Perez Torres (Chair)
Quality Specialist
AstraZeneca

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.