About me
Sumitra is a Regulatory Consultant at the Health Sciences Authority (HSA) in Singapore, heading the GCP Compliance Inspection Unit, which oversees Good Clinical Practice (GCP) inspections and quality improvement for clinical trials. She is the Topic Lead representing HSA at the ICH E6 (R3) Expert Working Group, which is responsible for revising the Good Clinical Practice (GCP) guideline. With 28 years of experience in monitoring, project management, academia, auditing, and GCP inspections across private and public sectors, she brings deep expertise to clinical trials.