SID & GP strengthens interaction between international regulators
On September 6, 2018 Vladislav Shestakov – Deputy Head of the Russian Inspectorate, Director of the State Institute of Drugs and Good Practices of the Russian Ministry of Industry and Trade – was on a business tour in Italy.
As part of the trip, he visited the Fedegari production facility, where Vladislav Shestakov had a professional meeting with Giuseppe Fedegari (Head of the Fedegari Group), Gilbert Ferraroli (CEO of the company Fedegari), Pierre Winnipins (founder of the No Deviation), and Yaroslav Anfossi (Fedegari’s sales manager).
The parties discussed opportunities of organizing educational and training workshops for inspectorates of the two countries.
‘The Russian GMP-inspectorate complies with the norms and rules of countries that enjoy high quality control system: we are making every effort to create a trustworthy image of our inspectors and secure global outreach. These days it is vital to exchange experience and discuss existing opportunities for development and interaction. The “Pharma 2030” strategy has an ambitious goal to increase export potential tenfold. We are strengthening interaction between international regulators, which will contribute to enhancement of export capacity of both countries,’ said Vladislav Shestakov.
Deputy Head of the Russian inspectorate suggested scheduling an educational workshop on aseptic manufacturing for GMP inspectors of Russia, Belarus, Kazakhstan, Kyrgyzstan, and Armenia in either Russia or Italy. Thematic seminars for international inspectorates should be planned on an ongoing basis.
- 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