Expert of FSI “SID & GP” spoke at P-MEC China Webinar

Ivan Guliaev, Head of the Training and Development Division of the Pharmaceutical Inspectorate of FSI “SID & GP” and Victor Dmitriev, General Director of the Association of Russian Pharmaceutical Manufacturers (ARPM) and Aleksei Savin, Managing Director for Eastern Europe of the IQVIA, were invited in their expert capacity.

The representative of the Russian GMP-inspectorate outlined in his presentation the way in which the GMP-inspection of the equipment for drugs manufacturing is organized. Tendencies of critical and major non-conformities, along with an examination of case studies of numerous typical non-conformities, related to manufacturing equipment of drug manufacturers, were analysed in depth.

Besides, during the webinar questions pertinent to the regulation of Russia’s pharmaceutical market as a whole were raised. In addition, issues regarding the transition to common rules of the EAEU were addressed, review of the dynamics and main development trends of the pharmaceutical development in the markets of the CIS countries were presented and issues relating to the organization of GMP inspections during the pandemic were also discussed.