PDA 2019 – UNDERSTANDING …
28 February 2019
TECHNOLOGICAL BREAKTHROUGH
28 March 2019FEDEGARI TO COOPERATE WITH THE RUSSIAN FEDERAL STATE INSTITUTION
Fedegari proudly signed a Memorandum on Cooperation with the Russian Federal State Institution – FSI – State Institute of Drugs and Good Practices
RUSSIA, September 2017 – During the last Russian GMP Conference in Gelendzhik Giuseppe Fedegari, President of Fedegari Group and Vladislav Shestakov, Director of Federal State Institute «State Institute of Drugs and Good Practices» of Russia, signed a Memorandum on Cooperation for the development of a very challenging project.
Fedegari will collaborate with FSI for the development of a training program of the Russian inspectors and operator in the field of pharmaceutical manufacturing processes.
Fedegari is proud to be partnering with FSI for the development of such an ambitious project and will share its experience in running the various Tech Centers in Italy, in the US and the latest one in Singapore (yet to be completed) where several regulatory bodies have already sent their inspectors to be trained. This is a time of great opportunities for the bio/pharmaceutical world an for the advancement of many technologies.
TECH CENTERS & TRAINING FOR INSPECTORS
Fedegari is proud to be partnering with FSI for the development of such an ambitious project and will share its experience in running the various Tech Centers in Italy, in the US and the latest one in Singapore (yet to be completed) where several regulatory bodies have already sent their inspectors to be trained. This is a time of great opportunities for the bio/pharmaceutical world an for the advancement of many technologies. A collaboration as the one subject of the aforesaid Memorandum on Cooperation will definitely bring significant benefits to both parties in the near future and make the Russian bio/pharmaceutical industries more competitive on the global scenario. As a part of the official Conference opening, a number of significant agreements have been signed. Strategic partnership as the one between Fedegari and the Russian Federal State Institution will promote the development and implementation of the scientific and technological potential of the pharmaceutical industry in Russia.
The agreement between Fedegari and FSI represents a mutual interest in achieving the following targets:
- Realization of research and applied scientific-practical tasks by joint efforts.
- Training of specialists in the pharmaceutical field.
- Advance of basic and additional professional education quality by involving the results of applied scientific and research activities in education.
- Assistance and supplying of specifications for pharmaceutical demonstration equipment to the production site of the educational center of FSI \”SID and GP\” with further maintenance and operational support procedures by Fedegari Group.
INSPECTORATE & MANUFACTURERS
“GMP is philosophy, culture of production that allows us to create responsibility in order to grow into super-quality – Sergei Tsyb, Deputy Minister of Industry and Trade. We succeeded in shaping the correct sectoral thinking in this area. Over one year and a half we managed to form a definite opinion to our Inspectorate. This is connected with systematic work, including serious personnel training”, said Vladislav Shestakov.
“Over one year and a half, about 580 inspections of foreign medicines manufacturers were conducted. All the work that is done by our Inspectorate is not only inspecting of foreign manufacturers, it is also inspecting of Russian enterprises. It is aimed at creating reputation, so that the certificates of our inspection are trusted in other countries. Here we are currently actively working with the Ministry of Industry and Trade and the Ministry of Health of the Russian Federation on accession to the PIC/S. This will give the opportunity to interact with the inspectors of other countries on a professional basis”, concluded Shestakov.
The Second All-Russian GMP-Conference with international participation
The Second All-Russian GMP-Conference dedicated to the current topic of inspection, compliance with the standard of Good Manufacturing Practice at pharmaceutical enterprises of the industry took place on September 18, in Gelendzhik. The Second GMP-Conference gathered more than 800 participants, 155 companies – twice more than the last year. The event, which has become traditional, brought together leading experts of the pharmaceutical industry, managers and specialists of production, representatives of line ministries and departments, associations, specialists in the field of professional development of the pharmaceutical industry staff. The Conference program opened with press-briefing, the participants of which were: Deputy Minister of Industry and Trade of the Russian Federation Sergei Tsyb, Director of Federal State Institute «State Institute of Drugs and Good Practices» of the Minpromtorg of Russia Vladislav Shestakov, Deputy Governor of the Krasnodar region Sergey Altukhov, Director of the Department for Medicines Supply and Regulation of Medical Devices Circulation of the Ministry of Health of the Russian Federation Elena Maksimkina, Head of the Department for organization of state control for the quality of medical products of Roszdravnadzor Valentina Kosenko, the first pro-rector of the First Moscow State Medical University named after I.M. Sechenov Andrey Svistunov, management of major companies «Pharmstandart», «Veropharm», «Aktivniy component».
Russian GMP Inspectorate Federal State Institute of Drugs and Good Practices
Fedegari is pleased to host in its booth at Achema 2018 representatives from the Federal State Institute of Drugs and Good Practices. Mr. Vladislav Shestakov, Director of Federal State Institute, will be present at Fedegari booth from June 13th to 15th.
The presence of FSI representatives at Achema is the result of the partnership started on September 2017 when Fedegari and FSI signed a Memorandum on Cooperation for the development of a training program of the Russian inspectors and operators in the field of pharmaceutical manufacturing processes.
