Vladislav Shestakov, Director of the FSI “State Institute of Drugs and Good Practices” (FSI “SID & GP”), spoke at the Roskachestvo business conference marking the 30th anniversary of the Russian Federation Government Quality Award

Director of the FSI “State Institute of Drugs and Good Practices (FSI “SID & GP”) Vladislav Shestakov delivered a presentation titled “Quality as a Strategy: The Legacy and Traditions of the Government Quality Award.”

In his remarks, the Director of FSI “SID & GP” emphasized that in the pharmaceutical industry, quality goes far beyond formal compliance with standards. He noted that the quality of medicines is integral to every stage of a drug’s life cycle — from molecule development and scientific research through to the release of the finished product.

A dedicated section of the presentation focused on the historical context that shaped today’s pharmaceutical quality regulation system. Vladislav Shestakov reminded the conference participants of the tragedy that occurred in the 1950s — one of the largest man-made disasters caused by the Thalidomide.

“That event was a turning point. It made humanity realize that ensuring basic safety was not enough; a comprehensive, in-depth evaluation of drugs at every stage of production was needed,” the Director of FSI “SID & GP” noted.

It was that disaster that provided a powerful impetus for the development and tightening of pharmaceutical regulation.

As Vladislav Shestakov observed, this led to the introduction of modern Good Manufacturing Practice (GMP) standards, along with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).

Today, the speaker stressed, the pharmaceutical industry is one of the most heavily regulated in the world. This is not a burden, but a prerequisite: each good practice addresses a specific area of risk, and together they form a reliable patient protection system.

Speaking about contemporary challenges, Vladislav Shestakov noted that in the era of biotechnological progress, both the quality of new medicines and their accessibility remain key priorities for healthcare systems. According to him, the industry is gradually moving from simple quality control to comprehensive quality management, where each process and stage is a link in a single chain that directly affects the quality of the final product.