Regulatory Considerations DMEG Update
Date: December 4, 2025
With mixed feelings, we share that Silvia Pérez Torres, current chair of the ACDM Regulatory Considerations DMEG, will step down after five years of dedicated service. As a founding member, Silvia helped launch the DMEG in February 2021. Silvia set a clear vision, built a high‑performing, inclusive team across the world, and cultivating a culture of collaboration and excellence across the group and the wider ACDM community.
Under Silvia’s leadership, the DMEG coordinated consensus feedback to regulators on key publications from ICH, EMA, and FDA, and translated evolving requirements—such as ICH E6(R3), ICH E8(R1), FDA Digital Health Technologies, Data Monitoring Committees, and the Q&A on Electronic Systems, Records, and Signatures—into practical guidance and best practices for data management. She also helped connect the community through initiatives like the Hot Topic session on ICH E6(R3) and the ACDM publication, “Getting Started with Audit Trail Review in Clinical Trial Data.”
Thank you, Silvia, for your leadership, team building, and collaborative spirit—your impact on our community is lasting.
Looking ahead, Linda Shostak, a current DMEG member, will assume the chair role in January 2026. Silvia and Linda will work closely to ensure a smooth transition and continued momentum into 2026. Please join us in thanking Silvia for her outstanding service and in welcoming Linda to her new leadership role.
If you are interested in learning more about the Regulatory considerations DMEG or are interested in joining the group you can locate us on the ACDM website here.
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ACDM Comments on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability”
https://acdmglobal.org/wp-content/uploads/2022/04/ACDM_FDA_DHT.pdf
