Mikhail Kamkha is a distinguished professional with over 16 years of expertise in quality management, regulatory compliance, and clinical research. Currently, he serves as a Lecturer at the Advanced Engineering School of Lomonosov Moscow State University, where he specializes in Quality Management Systems, ISO 9001, Good (x) Practices, Risk Management, Business Analytics, and Operational Management. Concurrently, Mikhail holds the pivotal role of Quality Professional with experience at global CROs and Intenational Pharmaceutical companies. In this capacity, he is instrumental in implementing ISO 9001:2015 standards, integrating Business Analytics for data-driven decision-making, and ensuring regulatory compliance across global operations. His expertise encompasses the development, implementation, and oversight of Quality Management Systems (QMS), regulatory compliance, audit and inspection management, risk management, operational functions, and continuous improvement initiatives. Mikhail's extensive professional background includes significant positions such as Clinical Optimization Manager, Clinical Team Manager, and Lead Clinical Monitor at a US-based global Clinical Research Organization (CRO). In these roles, he optimized clinical trial processes, managed clinical teams, and ensured adherence to international Good Clinical Practice (GCP) guidelines. Additionally, he has worked as a freelance GCP, Good Pharmacovigilance Practice (GVP), and ISO 9001:2015 Auditor, conducting independent audits to ensure compliance with regulatory requirements. With a robust educational foundation, Mikhail holds degrees from the First Moscow Sechenov State Medical University and has completed numerous (over 100) professional development courses in Business Intelligence, Six Sigma, Quality Management Systems, and Project Management. He is a certified Corporate Quality Management and GxP Professional, skilled in inspection readiness and pre-audit preparation across various legislations. Notably, Mikhail is RQA certified in Quality Management Systems (QMS) and Good Clinical Practice (GCP). Mikhail is an active member of the Research Quality Association and has successfully passed sponsor audits and inspections in clinical trials and pharmacovigilance systems in multiple regions, including the (EMA, FDA, PMDA, Asia and CIS countries). His expertise and leadership in Quality Management Systems make him a valuable asset in the field of clinical research and regulatory compliance.