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Closed Session for Regulators: Enhancing Competencies and New Horizons for Pharmaceutical Inspectors

Within the framework of the III International Forum of Pharmaceutical Inspectorates (IFPI), a closed session for representatives of national regulatory authorities will be held on the topic «Enhancing Competencies: New Horizons for Pharmaceutical Inspectors. Seeing What's Hidden for Impeccable Results».

The session will focus on practical issues of improving the effectiveness of GMP inspections, enhancing the professional competencies of inspectors, and developing the quality management system of pharmaceutical inspectorates.

During the session, experts will evaluate the role of the quality management system in the inspectorate's activities, analyze approaches to ensuring consistency and reproducibility of inspection activities, and suggest tools to maintain a high level of work quality for inspectors.

Special attention will be paid to practical aspects of conducting inspections. Experts will examine key principles of effective inspector behavior at various stages of inspection, approaches to collecting and evaluating evidence, interacting with representatives of the inspected enterprise, and forming objective conclusions based on inspection results.

Additionally, experts will thoroughly cover the procedure for applying a risk-based approach in forming inspection plans and demonstrate how risk assessment results can be used to determine priorities, frequency, and scope of inspections, and consequently, more efficient allocation of resources for the inspectorate. A significant part of the session program will be dedicated to the results of IFPI Working Groups' activities for 2026, including discussions of joint inspection results.

Thus, the closed session will serve as a platform not only for discussing approaches to improving GMP inspections but also for summarizing the practical results of IFPI Working Groups' activities for 2026.

Representatives of national regulatory authorities are invited to join the IFPI Working Groups and participate in international professional experience exchange. To participate, please fill out the application form via the link — https://ifpi-forum.com/groups

The III International Forum of Pharmaceutical Inspectorates will be held on November 16–17, 2026, in Hanoi, Vietnam.