Lina Gudima is a regulatory professional with 18 years of progressively responsible experience in the governance of medicines and medical devices. She served as Deputy Director General of the Agency for Medicines and Medical Devices (AMDM) from 2021 to 2025, where she led strategic initiatives in drug authorization, clinical trials regulation, and pharmacovigilance. Her early career encompassed five years in drug authorization, providing pivotal oversight for the safe and effective introduction of new drugs to the market. Over the subsequent 13 years, she expanded her remit to regulatory activities in clinical trials and pharmacovigilance, culminating in 11 years of leadership in Good Clinical Practice (GCP) inspections. A respected member of the EMA GCP Inspectors Working Group, Lina contributed to harmonization efforts that advance consistency and quality in clinical research. Notably, she co-led the drafting of the Medicines Law (2025) with the AMDM team, updating the clinical trials chapter and crafting the subsequent legal framework to align national practice with international standards. Her work reflects a commitment to patient safety, robust regulatory science, and effective governance of clinical research and pharmacovigilant