Visit of SID&GP to the USA
From July 17 to 25, 2017, SID&GP delegation went on the to the USA. The delegation included Vladislav Shestakov, Director of the State Institute of Drugs and Good Practices, Igor Falkovsky, Head of GEP Department, Mikhail Morozov, Head of International Cooperation Department, Vladimir Orlov, Deputy Head of Educational Center.
The program outline included the United States Department of Health and Human Services (Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority), Parenteral Drug Association, Pharmaceutical Research and Manufacturers of America, International Society for Pharmaceutical Engineering, Food and Drug Law Institute, University of Maryland School of Pharmacy, Keck School of Medicine of USC, University of Southern California School of Pharmacy as well as other pharmaceutical organizations and production sites, including Amgen Inc.
The trip was introductory in nature. The participants learned about the structure of FDA, regulatory framework of the USA concerning pharmaceutical industry, work of PDA, PhRMA, ISPE, discussed educational activity with regulators and joint educational modules. Departments and associations proposed to examine their structures and work in order to exchange relevant experience. While visiting Amgen Inc., delegation got acquainted with the company’s leadership, had a tour over production capacities (R&D), discussed the processes of quality control and risk management.
The delegation was introduced to Dr. Daniela Drago, an internationally recognized expert in the field of regulation of Rx drugs, medical equipment, cosmetics, foods and other consumer goods. She will speaker at the II All-Russia GMP Conference, on 18-20 September 2017 in Gelendzhik.
The visit resulted in agreement on experience and academic exchange. Together with Keck School of Medicine and University of South Carolina, SID&GP reached an agreement on creating joint educational modules and on sending two students to get master’s degrees in biopharmaceutics.
ISPE leadership was invited to participate in the opening ceremony of the Eurasian Affiliate of ISPE (Moscow, October 2017) and introduction of the Eurasian ISPE Affiliate at a joint ISPE and FDA conference (San-Diego, October-November 2017).
Articles on the SID&GP activity and Russian Inspectorate will be published in FDLI magazine and PDA issue before the end of the year. Please check our website for updates.
- The traditional workshop at the GMP Conference to be held as a game-based quest
- Revised Guidelines on Data Integrity and Validation of Computerised Systems
- Experience of Independent Examination in Pharmaceutical Manufacturing
- Vladislav Shestakov: “Time not to contemplate, but to act!”
- The third GLP-PLANET Conference to take place in St. Petersburg